Development and Validation of Analytical Methods for Estimation of Antidiabetic Drugs in Pharmaceutical Formulations

Jitendra More, Dr. Shailesh B. Patil,

doi:10.5281/zenodo.15882086

Research Paper | Open Access
Volume 03 | Issue 07 | Article Id IJPS/250307139

Development and Validation of Analytical Methods for Estimation of Antidiabetic Drugs in Pharmaceutical Formulations
Jitendra More* Dr. Shailesh B. Patil
¹Prof. Ravindra Nikam College of Pharmacy, Gondur, Dhule.
²DCS’s ARA College of Pharmacy, Nagaon, Dhule.

Abstract

A robust, accurate, and precise Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the quantitative estimation of Pioglitazone in Pioz 7.5 tablet dosage form. In addition, a UV-Visible spectrophotometric method was developed for the simultaneous estimation of commonly prescribed antidiabetic drugs, including Glibenclamide, Glipizide, Gliclazide, and Pioglitazone in both bulk and tablet formulations. The RP-HPLC analysis was carried out at a detection wavelength of 270 nm. Chromatographic parameters such as specificity, linearity, accuracy, precision, sensitivity, robustness, and stability were evaluated as per ICH guidelines. The method showed good specificity with no interference at the retention time. Linearity was observed in the concentration range of 20–100 µg/mL, with a correlation coefficient close to 1. Accuracy was 98.99%, and the method exhibited high precision with intra-day and inter-day %RSD values of 100.58% and 101.2%, respectively. The recovery rate was 99.50%, and repeatability was within acceptable limits (0.55%). The method demonstrated good sensitivity with a limit of detection (LOD) of 3.78 µg/mL and a limit of quantification (LOQ) of 11.47 µg/mL. Robustness was confirmed with a %RSD of 0.66%. No significant drug interactions were observed, indicating stability of the formulation. B The UV-Visible method also demonstrated excellent specificity, with no interference at ?max for all tested drugs. The results satisfied the acceptance criteria for accuracy (98–102%) and precision (%RSD ? 2%). In conclusion, both methods are reliable, reproducible, and suitable for routine quality control of these antidiabetic agents in pharmaceutical dosage forms.

Keywords

HPLC, Glibenclamide, Glipizide, Gliclazide, Pioglitazone etc

Introduction

Accurate quantification of active pharmaceutical ingredients (APIs) is critical in ensuring drug safety and efficacy. This study focuses on the development and validation of UV-Visible and RP-HPLC methods for estimating sulfonylureas and thiazolidinedione class drugs in tablet dosage forms.^[1-3]

MATERIALS AND METHODS:

Materials: Standard drugs and tablets: Glibenclamide (Glybovin 5), Glipizide (Glynase 5), Gliclazide (Reclide MR 30), Pioglitazone (Pioz 7.5) procument from local market of Dhule. All chemicals and solvents used were of analytical reagent grade Loba Chem Mumbai.^[4-7]

Instrumentation: - UV-Vis Spectrophotometer: Shimadzu UV-1700 - HPLC: Agilent 1100 Series with C18 column.

Table no. 01: HPLC parameters for method development and validation of Pioglitazone (API), and Pioz 15 tablet:

Detection type	Double beam photometer
Light Source	Deuterium lamp
Wavelength Range	220 - 350 nm
Linear Absorbance range	> 2 AU (5%) upper limit
Wavelength accuracy	± 1 nm
Control and Data Evaluation	Agilent Chem Station for LC
Column	C18 (Octadecylsilane)
Mobile Phase	Acetonitrile: Acetic Acid: Water various combinations
Flow Rate	10 μL volume
Detection Wavelength (nm)	270 nm
Injection Volume	10 μL volume

Method development: Materials Needed:

Stock solution 100 mg /100 ml pioglitazone.
Solvent as Acetonitrile: Acetic Acid: Water.
Pipettes (micro-pipettes) and pipette tips.
Volumetric flasks or standard test tubes
Labels and marker it.

Procedure:

Calculate the required volumes:

Use the formula: C1×V1=C2×V2

Where: C1?= concentration of stock solution, V1= volume of stock solution to be used,

C2?= desired concentration of the diluted solution, V2?= final volume of the diluted solution

Prepare the dilutions:

Assuming the stock solution concentration (C1) is 1000 μg/mL

A. 10 µg/mL Dilution:

- Desired concentration (C2): 10 µg/mL.
- Final volume (V2): 10 mL.
- Calculate V1 (volume of stock solution needed):

Measure 0.1 mL of the stock solution and dilute to 10 mL with solvent.
Likewise prepare 20, 30, 40, 50 and 60 µg/mL Dilution.
Stock solutions 0.2, 0.3, 0.4, 0.5 and 0.6 mL of the stock solution and dilute to 10 mL with solvent.

Calibration Curve Preparation: Stock solutions (1000 µg/mL) were prepared in methanol. Serial dilutions (2–10 µg/mL) were analyzed at λmax specific to each drug: - Glibenclamide: 230 nm - Glipizide: 275 nm - Gliclazide: 227 nm - Pioglitazone: 274 nm ^[8-18]

Absorbance Method or Direct Measurement:

Preparation of each different drug Stock solution: 1mg drug dissolved in 1ml methanol (1000 µg/mL or 1mg/ml)
Prepare working standard solutions for each drug : Prepared series of dilution from above stock solution (2–10 µg/mL) linear range of dilution in a solvent methanol.
Measure absorbance at 230, 275, 227, and 274 nm using a UV spectrophotometer.
Plot graph absorbance vs. concentration to obtain a calibration curve by using software Microsoft Excel: ^[19-20]

RESULTS AND DISCUSSION:

Select Method 1 (Acetonitrile: Acetic Acid: Water, 50:20:30 v/v/v) with an RT of 1.9 and 2.1 min for further analytical method validation of Pioz 7.5 (pioglitazone) tablet by using HPLC method. To validate the analytical method for Pioz 7.5 (pioglitazone) tablet in terms of specificity, linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), robustness, and stability.

Table no. 02: Various composition of mobile phase for method development for Pioz 7.5 tablet:

Method	Mobile Phase	Ratio of Mobile phase	RT	Run Time
	Acetonitrile: Acetic Acid: Water	50:20:30 v/v/v	2.1 min	20 min
	Acetonitrile: Acetic Acid: Water	30:30:40 v/v/v	4.5 min	20 min
	Acetonitrile: Acetic Acid: Water	40:20:40 v/v/v	4.0 min	20 min

Figure no. 02: Various composition of mobile phase for method development for Pioz 7.5 tablet retention time and run time of pharmaceutical dosage form at 270 nm.

Results of Validation Parameters:

Specificity: Inject blank/placebo, standard, and sample solutions to ensure no interference at the retention time of Pioz 7.5 (pioglitazone) tablet

Figure no. 03: Specificity of pioglitazone for test sample, STD sample and placebo sample.

Table no. 03: Result of Specificity test for method development of Pioglitazone pharmaceutical dosage form:

Sr. No.	Name of sample	Ratio of Mobile phase	RT	Run Time
	Std. sample of pioglitazone	Acetonitrile: Acetic Acid: Water 50: 20: 30 v/v/v	2.0 min	20 min
	Test sample of Pioz 7.5 tablet	Acetonitrile: Acetic Acid: Water 50: 20: 30 v/v/v	2.2 min	20 min
	Placebo sample	Acetonitrile: Acetic Acid: Water 50: 20: 30 v/v/v	00 min	20 min

N=06

Linearity: Prepare standard solutions at five concentration levels (2, 4, 6, 8, and 10 µg/mL). Plot the peak area versus concentration and calculate the correlation coefficient (R²).

Table no. 04: Result of Linearity of Pioz 7.5 tablet with different concentrations:

Concentration	Area of Peak	RT
20 µg/mL	30 mAU	2.00
40 µg/mL	61 mAU	2.01
60 µg/mL	90 mAU	2.2
80 µg/mL	123 mAU	2.1
100 µg/mL	240 mAU	2.05

N=06

Figure no. 04: Linearity of Pioz 7.5 tablet with different concentrations.

Accuracy: Perform recovery studies at three levels (80%, 100%, and 120%) by spiking known amounts of Pioz 7.5 tablet into the placebo. Calculate the percentage recovery.

Table no. 05: Result of Accuracy of Pioz 7.5 tablet with same concentrations:

Normal concentration	Concentration found	RT
10 µg/ml	10.09 µg/ml	2.0
10 µg/ml (1)	10.01 µg/ml	2.1
10 µg/ml (2)	09.95µg/ml	2.1
10 µg/ml (3)	10.03µg/ml	2.1

N=06

Figure no. 05: Accuracy of Pioz 7.5 tablet with same concentrations.

Precision: Repeatability: Inject six replicates of 20 µg/mL standard solution and calculate the % RSD.

Intermediate Precision: Perform the analysis on different days, by different analysts, and with different instruments.

Table no.06: Result of Inter day precision:

Normal concentration	Concentration found	SD	Precision C.V. %	Accuracy	% R.S.D.
00 µg/mL	00 µg/mL	-	-	-	-
10 µg/mL	10.70 µg/mL	0.343	105.02	100.2	3.20
20 µg/mL	20.14 µg/mL	0.465	105.0	105.1	2.21
40 µg/mL	40.12µg/mL	0.382	96.01	96.04	0.94
80 µg/mL	80.75 µg/mL	0.573	92.02	100.01	0.71
100 µg/mL	99.74 µg/mL	0.701	94.00	100.02	0.71

Table no. 07: Result of Intraday precision:

Normal concentration	Concentration found	SD	Precision C.V. %	Accuracy	% R.S.D.
00 µg/mL	00 µg/mL	-	-	-	-
10 µg/mL	10.15 µg/mL	0.381	104.00	101.21	3.66
20 µg/mL	20.29 µg/mL	0.342	101.0	102.10	1.66
40 µg/mL	40.04µg/mL	0.525	100.01	10104	1.29
80 µg/mL	80.18 µg/mL	0.364	99.02	101.02	0.45
100 µg/mL	99.24 µg/mL	0.702	94.02	100.02	0.71

N=06

Recovery:

Recovery = [(A – B)/C] × 100 Where A is a quantity of pioglitazone standard, B is a quantity of Pioz 7.5 tablet; C is a quantity of added

Table no. 08: Result of % Recovery of Pioz 7.5 tablet: N=06

Normal concentration	Concentration found	Recovery concentration	% Recovery	% R.S.D.
20 + 100 µg/mL	118.99 µg/mL	19.59 µg/mL	97.50	0.65
40 + 100 µg/mL	139.41 µg/mL	39.54µg/mL	98.85	0.28
80 + 100 µg/mL	179.28 µg/mL	79.28 µg/mL	99.10	0.44

Repeatability: The repeatability of Pioz 7.5 tablet refers to the consistency of its therapeutic effects and pharmacokinetics when administered repeatedly under the same conditions.

Table no. 09: Result of Repeatability of Pioz 7.5 tablet: N=06

Normal concentration	Concentration found	% Concentration found	SD
40 µg/mL	39.70 µg/mL	98.55	0.638
40 µg/mL	39.54 µg/mL	97.59	0.536
40 µg/mL	39.62µg/mL	98.12	0.601
40 µg/mL	39.74 µg/mL	98.75	0.731
40 µg/mL	39.05 µg/mL	95.26	0.482
40 µg/mL	39.03 µg/mL	95.18	0.455

Limit of Detection (LOD) and Limit of Quantification (LOQ): Calculate LOD and LOQ using the standard deviation of the response and the slope of the calibration curve (LOD = 3.3σ/S, LOQ = 10σ/S) for Pioz 7.5 tablet.

LOD

= 3.3 x 1.147/0.9993

= 3.78 µg/mL

LOD

= 10 x 1.147/0.9993

=11.47 µg/mL

Robustness: Evaluate the effect of small deliberate changes in chromatographic conditions (e.g., flow rate ± 0.1 mL/min, wavelength ± 2 nm, and mobile phase composition) on the retention time and peak area for Pioz 7.5 tablet.

Table no. 10: Result of Robustness of different composition of mobile phase for Pioz 7.5 tablet:

Mobile phase: Acetonitrile: Acetic Acid: Water 50: 20: 30 v/v/v
Normal concentration	Concentration found	RT	SD	% R.S.D.
20 µg/mL	20.62 µg/mL	2.1	0.346	1.67
40 µg/mL	40.56µg/mL	2.1	0.529	1.30
80 µg/mL	80.34 µg/mL	2.1	0.369	0.45
Mobile phase: Acetonitrile: Acetic Acid: Water 40: 20: 40 v/v/v
Normal concentration	Concentration found	RT	SD	% R.S.D.
20 µg/mL	19.56 µg/mL	4.2	0.682	3.48
40 µg/mL	39.56µg/mL	4.2	0.598	1.51
80 µg/mL	79.54 µg/mL	4.2	0.525	0.66

N=6

The robustness study of the Acetonitrile: Acetic Acid: Water 50: 20: 30 v/v/v mobile phase showed consistent results across different concentrations of Pioz 7.5 tablet. At concentrations of 20 µg/mL, 40 µg/mL, and 80 µg/mL, the method exhibited good precision with relative standard deviations (R.S.D.) ranging from 0.45% to 1.67%. The retention times (RT) were stable between 2.1 minutes, indicating reliable chromatographic performance under these conditions.

Stability: Assess the stability of Pioz 7.5 tablet in sample solutions at room temperature and refrigerated conditions over 24 and 48 hours.

Table no. 11: the stability of Pioz 7.5 tablet in sample solutions at room temperature and refrigerated conditions over 24 and 48 hours:

Room temp conditions	Normal concentration	Concentration found	RT	SD	% R.S.D.
00 hrs.	80 µg/mL	80.10 µg/mL	2.1	0.364	0.45
24 hrs.	80 µg/mL	80.12 µg/mL	2.1	0.368	0.46
48 hrs.	80 µg/mL	80.18 µg/mL	2.1	0.374	0.49
Refrigerated conditions	Normal concentration	Concentration found	RT	SD	% R.S.D.
00 hrs.	80 µg/mL	80.11 µg/mL	2.2	0.365	0.45
24 hrs.	80 µg/mL	80.14 µg/mL	2.2	0.370	0.47
48 hrs.	80 µg/mL	80.22 µg/mL	2.2	0.389	0.49

N= 6

Based on the results, Pioz 7.5 tablet in sample solutions is stable at room temperature for up to 48 hours without significant degradation. Refrigerated conditions further enhance its stability, maintaining the concentration within acceptable limits over the same duration. These findings support the suitability of both room temperature and refrigerated storage for maintaining the stability of Pioz 7.5 tablet solutions over a short-term period.

Table no. 12: Validation parameters result for Pioz 7.5 tablet:

Sr. No.	Parameters	Results
	Working wavelength	270 nm
	Specificity	No interferences
	Linearity range (µg/mL)	20 µg/mL to 100 µg/mL
	Accuracy	98.99 %
	Precision (% RSD)
	Inter-day Precision	101.2 %
	Intra-day Precision	100.58 %
	% Recovery	99.50 %
	Repeatability (Mean ± SD)	0.55 %
	LOD and LOQ	3.78 and 11.47 µg/mL
	Robustness (% RSD)	0.66 %
	Stability	Stable no interaction

The developed RP-HPLC method for Pioz 7.5 tablet exhibited a working wavelength of 270 nm with good specificity and no interference observed. The method showed linearity in the concentration range of 20–100 µg/mL. Accuracy was found to be 98.99%, while precision (%RSD) values were 100.58% (intra-day) and 101.2% (inter-day), indicating high reproducibility. Recovery was 99.50%, and repeatability was 0.55% (Mean ± SD). The method demonstrated suitable sensitivity with LOD and LOQ values of 3.78 µg/mL and 11.47 µg/mL, respectively. Robustness (%RSD) was 0.66%, and the drug was stable with no significant interaction observed. A Result of Standard Calibration Curve study was conducted to evaluate it is fundamental in analytical method development, especially in UV-Visible spectroscopy (Shimadzu UV-1700 Series), HPLC (Agilent 1100 series), and other quantitative assays for active pharmaceutical ingredients (APIs) and pharmaceutical product of Glibenclamide (Glybovin 5 tablet), Glipizide (Glynase 5 tablet), Gliclazide (Reclide MR 30 Tablet), and Pioglitazone (Pioz 7.5 tablet):

Table no. 13: Result of standard Calibration curve and Validation Parameters (n = 6):

Drug / Product	λmax (nm)	Calibration Equation	R² Value	% Recovery (Mean ± SD)	%RSD Intra-day	%RSD Inter-day	LOD (µg/mL)	LOQ (µg/mL)
Glibenclamide	230	y = 0.0734x	0.9996	99.12–100.86 ± 0.45%	0.76%	0.88%	3.781	11.473
Glybovin 5 tablet	230	y = 0.0746x	0.9997	99.12–100.86 ± 0.45%	0.76%	0.88%	3.781	11.473
Glipizide	275	y = 0.0696x	0.9996	98.91–100.42 ± 0.52%	0.65%	0.79%	3.780	11.473
Glynase 5 tablet	275	y = 0.0705x	0.9997	98.91–100.42 ± 0.52%	0.65%	0.79%	3.780	11.473
Gliclazide	227	y = 0.0765x	0.9999	99.34–101.02 ± 0.50%	0.63%	0.62%	3.785	11.471
Reclide MR 30 tablet	227	y = 0.0788x	0.9999	99.34–101.02 ± 0.50%	0.63%	0.62%	3.785	11.471
Pioglitazone	274	y = 0.0712x	0.9999	99.25–100.55 ± 0.48%	0.72%	0.91%	3.780	11.473
Pioz 7.5 tablet	274	y = 0.0746x	0.9997	99.25–100.55 ± 0.48%	0.72%	0.91%	3.780	11.473

CONCLUSION:

The developed RP-HPLC method for the analysis of Pioz 7.5 tablets proved to be accurate, specific, and reproducible. It operated effectively at a working wavelength of 270 nm, with no interference observed, confirming good specificity. The method exhibited excellent linearity over the concentration range of 20–100 µg/mL. Accuracy (98.99%) and precision (intra-day: 100.58%, inter-day: 101.2%) were within acceptable limits, indicating high reliability and reproducibility. The recovery rate (99.50%) and low repeatability value (0.55%) further support the method’s consistency. Sensitivity was confirmed with LOD and LOQ values of 3.78 µg/mL and 11.47 µg/mL, respectively, while robustness was acceptable (%RSD: 0.66%). Additionally, the drug showed good stability with no significant interactions. Similarly, the UV-Visible spectrophotometric method developed for Glibenclamide, Glipizide, Gliclazide, and Pioglitazone also met all standard validation parameters. It demonstrated no interference at λmax, and fulfilled the acceptance criteria for accuracy (98–102%), precision (%RSD ≤ 2%), and sensitivity (LOD/LOQ). Thus, both methods are validated and suitable for routine quantitative analysis of these antidiabetic drugs in bulk and tablet dosage forms.

Acknowledgment: The authors acknowledge Dr. Shailesh B. Patil and Dr. R. D. Wagh principal of DCS’s ARA College of Pharmacy, Nagaon, Dhule, for providing the necessary facilities and support throughout the research work.

REFERENCES

Wojnarowska Z, Grzybowska K, Adrjanowicz K, Kaminski K, Paluch M, Hawelek L, Wrzalik R, Dulski M, Sawicki W, Mazgalski J, Tukalska A. Study of the amorphous glibenclamide drug: analysis of the molecular dynamics of quenched and cryomilled material. Molecular pharmaceutics. 2010 Oct 4; 7(5):1692-707.
Delgadillo-Armendariz NL, Rangel-Vázquez NA, García-Castañón AI. Spectroscopy analysis of chitosan-glibenclamide hydrogels. Spectrochemical Acta Part A: Molecular and Biomolecular Spectroscopy. 2014 Feb 24; 120:524-8.
Ahmad A, Khan RM, Alkharfy KM. Development and validation of RP-HPLC method for simultaneous estimation of glibenclamide and thymoquinone in rat plasma and its application to pharmacokinetics. Acta Chromatographica. 2015 Sep; 27(3):435-48.
Rathor S, Bhatt DC. Novel Glibenclamide–Phospholipid Complex for Diabetic Treatment: Formulation, Physicochemical Characterization, and in-vivo Evaluation. Indian J. Pharm. Educ. Res. 2022 Jul 1; 56:697-705.
Rathor S, Bhatt DC. Novel Glibenclamide–Phospholipid Complex for Diabetic Treatment: Formulation, Physicochemical Characterization, and in-vivo Evaluation. Indian J. Pharm. Educ. Res. 2022 Jul 1; 56:697-705.
Ali F, Nandi U, Trivedi M, Prakash A, Dahiya M, Sahu PL, Kumar R, Singh GN. Quantitative characterization and pharmaceutical compatibility between teneligliptin and widely used excipients by using thermal and liquid chromatography tandem mass spectrometry techniques. Journal of Thermal Analysis and Calorimetry. 2018 Apr; 132:385-96.
Eesam S, Bhandaru JS, Akkinepally RR, Bobbala RK. Cocrystallization of gliclazide with improved physicochemical properties. Future Journal of Pharmaceutical Sciences. 2021 Jun 25; 7(1):124.
Eesam S, Bhandaru JS, Akkinepally RR, Bobbala RK. Cocrystallization of gliclazide with improved physicochemical properties. Future Journal of Pharmaceutical Sciences. 2021 Jun 25; 7(1):124.
Azadeh M, Gorovits B, Kamerud J, MacMannis S, Safavi A, Sailstad J, Sondag P. Calibration curves in quantitative ligand binding assays: recommendations and best practices for preparation, design, and editing of calibration curves. The AAPS journal. 2018 Jan;20:1-6.
Takla PG. Glibenclamide. In Analytical profiles of drug substances 1981 Jan 1 (Vol. 10, pp. 337-355). Academic Press.
Eapen C, Prasanth VG, Rai A. Development of UV spectrometric method of glibenclamide (glyburide) in bulk and pharmaceutical formulations. International Journal of Chem Tech Research. 2012 Jan;4(1):356-60.
Hsieh S, Selinger K. High-throughput bioanalytical method using automated sample preparation and liquid chromatography–atmospheric pressure ionspray mass spectrometry for quantitative determination of glybenclamide in human serum. Journal of Chromatography B. 2002 Jun 5;772(2):347-56.
Venkatesh P, Harisudhan T, Choudhury H, Mullangi R, Srinivas NR. Simultaneous estimation of six anti?diabetic drugs glibenclamide, gliclazide, glipizide, pioglitazone, repaglinide and rosiglitazone: development of a novel HPLC method for use in the analysis of pharmaceutical formulations and its application to human plasma assay. Biomedical Chromatography. 2006 Oct;20(10):1043-8.
Raul SK, Spandana B, Sameera P, Vikitha V. UV Spectrophotometric method development and validation for the estimation of gliclazide in bulk and pharmaceutical dosage form. Asian Journal of Pharmaceutical Analysis. 2016;6(3):143-6.
Atif M, Khalid SH, Kit GO, Sulaiman SA, Asif M, Chandersekaran A. Development and validation of RP-HPLC-UV method for the determination of Glipizide in human plasma. Journal of Young Pharmacists. 2013 Mar 1;5(1):26-9.
Pani NR, Acharya S, Patra S. Development and validation of RP-HPLC method for quantification of glipizide in biological macromolecules. International Journal of Biological Macromolecules. 2014 Apr 1;65:65-71.
Shankar MB, Modi VD, Shah DA, Bhatt KK, Mehta RS, Geetha M, Patel BJ. Estimation of pioglitazone hydrochloride and metformin hydrochloride in tablets by derivative spectrophotometry and liquid chromatographic methods. Journal of AOAC international. 2005 Jul 1;88(4):1167-72.
Al-Majed A, Bakheit AH, Aziz HA, Alharbi H, Al-Jenoobi FI. Pioglitazone. Profiles of Drug Substances, Excipients and Related Methodology. 2016 Jan 1;41:379-438.
Radhakrishna T, Rao DS, Reddy GO. Determination of pioglitazone hydrochloride in bulk and pharmaceutical formulations by HPLC and MEKC methods. Journal of pharmaceutical and biomedical analysis. 2002 Jul 20;29(4):593-607.
Sripalakit P, Neamhom P, Saraphanchotiwitthaya A. High-performance liquid chromatographic method for the determination of pioglitazone in human plasma using ultraviolet detection and its application to a pharmacokinetic study. Journal of chromatography B. 2006 Nov 7;843(2):164-9.

Reference

Wojnarowska Z, Grzybowska K, Adrjanowicz K, Kaminski K, Paluch M, Hawelek L, Wrzalik R, Dulski M, Sawicki W, Mazgalski J, Tukalska A. Study of the amorphous glibenclamide drug: analysis of the molecular dynamics of quenched and cryomilled material. Molecular pharmaceutics. 2010 Oct 4; 7(5):1692-707.
Delgadillo-Armendariz NL, Rangel-Vázquez NA, García-Castañón AI. Spectroscopy analysis of chitosan-glibenclamide hydrogels. Spectrochemical Acta Part A: Molecular and Biomolecular Spectroscopy. 2014 Feb 24; 120:524-8.
Ahmad A, Khan RM, Alkharfy KM. Development and validation of RP-HPLC method for simultaneous estimation of glibenclamide and thymoquinone in rat plasma and its application to pharmacokinetics. Acta Chromatographica. 2015 Sep; 27(3):435-48.
Rathor S, Bhatt DC. Novel Glibenclamide–Phospholipid Complex for Diabetic Treatment: Formulation, Physicochemical Characterization, and in-vivo Evaluation. Indian J. Pharm. Educ. Res. 2022 Jul 1; 56:697-705.
Rathor S, Bhatt DC. Novel Glibenclamide–Phospholipid Complex for Diabetic Treatment: Formulation, Physicochemical Characterization, and in-vivo Evaluation. Indian J. Pharm. Educ. Res. 2022 Jul 1; 56:697-705.
Ali F, Nandi U, Trivedi M, Prakash A, Dahiya M, Sahu PL, Kumar R, Singh GN. Quantitative characterization and pharmaceutical compatibility between teneligliptin and widely used excipients by using thermal and liquid chromatography tandem mass spectrometry techniques. Journal of Thermal Analysis and Calorimetry. 2018 Apr; 132:385-96.
Eesam S, Bhandaru JS, Akkinepally RR, Bobbala RK. Cocrystallization of gliclazide with improved physicochemical properties. Future Journal of Pharmaceutical Sciences. 2021 Jun 25; 7(1):124.
Eesam S, Bhandaru JS, Akkinepally RR, Bobbala RK. Cocrystallization of gliclazide with improved physicochemical properties. Future Journal of Pharmaceutical Sciences. 2021 Jun 25; 7(1):124.
Azadeh M, Gorovits B, Kamerud J, MacMannis S, Safavi A, Sailstad J, Sondag P. Calibration curves in quantitative ligand binding assays: recommendations and best practices for preparation, design, and editing of calibration curves. The AAPS journal. 2018 Jan;20:1-6.
Takla PG. Glibenclamide. In Analytical profiles of drug substances 1981 Jan 1 (Vol. 10, pp. 337-355). Academic Press.
Eapen C, Prasanth VG, Rai A. Development of UV spectrometric method of glibenclamide (glyburide) in bulk and pharmaceutical formulations. International Journal of Chem Tech Research. 2012 Jan;4(1):356-60.
Hsieh S, Selinger K. High-throughput bioanalytical method using automated sample preparation and liquid chromatography–atmospheric pressure ionspray mass spectrometry for quantitative determination of glybenclamide in human serum. Journal of Chromatography B. 2002 Jun 5;772(2):347-56.
Venkatesh P, Harisudhan T, Choudhury H, Mullangi R, Srinivas NR. Simultaneous estimation of six anti?diabetic drugs glibenclamide, gliclazide, glipizide, pioglitazone, repaglinide and rosiglitazone: development of a novel HPLC method for use in the analysis of pharmaceutical formulations and its application to human plasma assay. Biomedical Chromatography. 2006 Oct;20(10):1043-8.
Raul SK, Spandana B, Sameera P, Vikitha V. UV Spectrophotometric method development and validation for the estimation of gliclazide in bulk and pharmaceutical dosage form. Asian Journal of Pharmaceutical Analysis. 2016;6(3):143-6.
Atif M, Khalid SH, Kit GO, Sulaiman SA, Asif M, Chandersekaran A. Development and validation of RP-HPLC-UV method for the determination of Glipizide in human plasma. Journal of Young Pharmacists. 2013 Mar 1;5(1):26-9.
Pani NR, Acharya S, Patra S. Development and validation of RP-HPLC method for quantification of glipizide in biological macromolecules. International Journal of Biological Macromolecules. 2014 Apr 1;65:65-71.
Shankar MB, Modi VD, Shah DA, Bhatt KK, Mehta RS, Geetha M, Patel BJ. Estimation of pioglitazone hydrochloride and metformin hydrochloride in tablets by derivative spectrophotometry and liquid chromatographic methods. Journal of AOAC international. 2005 Jul 1;88(4):1167-72.
Al-Majed A, Bakheit AH, Aziz HA, Alharbi H, Al-Jenoobi FI. Pioglitazone. Profiles of Drug Substances, Excipients and Related Methodology. 2016 Jan 1;41:379-438.
Radhakrishna T, Rao DS, Reddy GO. Determination of pioglitazone hydrochloride in bulk and pharmaceutical formulations by HPLC and MEKC methods. Journal of pharmaceutical and biomedical analysis. 2002 Jul 20;29(4):593-607.
Sripalakit P, Neamhom P, Saraphanchotiwitthaya A. High-performance liquid chromatographic method for the determination of pioglitazone in human plasma using ultraviolet detection and its application to a pharmacokinetic study. Journal of chromatography B. 2006 Nov 7;843(2):164-9.

Jitendra More

Corresponding author

Prof. Ravindra Nikam College of Pharmacy, Gondur, Dhule.

Dr. Shailesh B. Patil

Co-author

DCS’s ARA College of Pharmacy, Nagaon, Dhule.

Jitendra More*, Dr. Shailesh Patil, Development and Validation of Analytical Methods for Estimation of Antidiabetic Drugs in Pharmaceutical Formulations, Int. J. of Pharm. Sci., 2025, Vol 3, Issue 7, 1928-1939. https://doi.org/10.5281/zenodo.15882086

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Development and Validation of Analytical Methods for Estimation of Antidiabetic Drugs in Pharmaceutical Formulations

Abstract

Keywords

Introduction

Reference

Jitendra More

Dr. Shailesh B. Patil

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