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  • Development And Validation of Stability Indicating RP-HPLC Method For Quantification of Bisoprolol Fumarate and Telmisartan in Tablet Dosage Form

  • Photo Mudra Solanki * Photo Pinak Patel Photo Shivani Jani Photo Rashmi Shukla Photo Krunal Detholia

  • 1,2,3,4Department of Pharmaceutical Quality Assurance, Smt. S. M. Shah Pharmacy College, Mahemdabad, Gujarat.

    5Department of Pharmaceutics, Smt. S. M. Shah Pharmacy College, Mahemdabad, Gujarat.

Abstract

Background: An anti-hypertensive drug having combination of Bisoprolol Fumarate and Telmisartan is used for the treatment of hypertension. Objective: This study aimed to develop, validate, and apply stability-indicating RP-HPLC method for quantitative estimation of Bisoprolol Fumarate and Telmisartan from Tablet dosage form. Method: Bisoprolol Fumarate and Telmisartan were separated by developing the Stability indicating RP-HPLC method on Hibar ODS C18 column (250 mm × 4.6 mm, 5 µm) in an isocratic mode using a mobile phase of Acetonitrile: 10 mM Phosphate Buffer (70: 30 v/v) with a flowrate of 1.0 ml/min and UV detection was carried out at 230 nm. Both drugs were subjected to stress conditions like acidic, basic, oxidative, and thermal degradation. Results: The proposed method is capable to separate and quantify the components from their combination. The proposed was able to detect the degradants of both drugs. The method was validated according to the guidelines described in the International Council for Harmonization guideline. Conclusion: The RP-HPLC method for assay of market formulations of Bisoprolol Fumarate and Telmisartan was successfully developed, validated, and found to be simple, accurate, precise, reproducible, sensitive, and robust and stability-indicating. Highlights: These findings suggested that the proposed RP-HPLC method can be employed in routine assay of Bisoprolol Fumarate and Telmisartan in combined formulation

Keywords

RP-HPLC, Forced Degradation studies, Assay, Bisoprolol Fumarate, Telmisartan.

Introduction

Bisoprolol fumarate is chemically 2-propanol,1-[4-[[2-(1-methylethoxy) ethoxy] methyl] phenoxy]-3-[(1-methylethyl) amino]-, (±)-, (E)-2-butenedioate. Bisoprolol fumarate is Cardioselective ?1-adrenergic blocking agent. It is used as an antihypertensive drug. Bisoprolol Fumarate was used in the management of hypertension, angina pectoris, cardiac arrhythmias, myocardial infarction, and heart failure. Telmisartan is chemically 4’-{[4-methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl- 1H-benzimidazol-1-yl] methyl]}-2-biphenyl-carboxylic acid. Telmisartan is an Angiotensin II receptor blockers (ARB). It is used as an antihypertensive drug. Telmisartan is used in the treatment of hypertension, heart attack, stroke, congestive heart failure (in patients who develop cough with ACE inhibitors). Also used in the treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes mellitus.

       
            Structure of Bisoprolol Fumarate.jpg
       
Figure 1: Structure of Bisoprolol Fumarate

       
            Structure of Telmisartan.png
       
Figure 2: Structure of Telmisartan

Literature surveys revealed that two UV [1-2], four RP-HPLC [3-6] and two HPTLC [7-8] methods have been reported for determination of Bisoprolol fumarate and Telmisartan in combined tablet dosage form. This combination used for treatment of hypertension. To our notice, so far, no stability-indicating RP-HPLC method has been reported for the determination of this combination. So, the estimation of the two drugs simultaneously can be done by stability-indicating RP-HPLC method.

 

Table 1: Instrumentation

 

Sr. no.

Instrument/Equipment

Specifications

1

HPLC

Make: Shimadzu

Model: LC 2010

Column: Hibar ODS C18 (250 × 4.6 mm, 5 µm)

Detector: UV

Pump: Binary gradient high-pressure pump

Software: LC solution

2

Applicator syringe

20 µL Hamilton, Bonaduz

3

UV-Visible Spectrometer

Make: Shimadzu

Model: UV 1800

Detector: Photodiode

Type: Double Beam spectrophotometer

Software: U.V. Probe 2.42

4

Analytical Balance

Make: Mettler Toledo

Sensitivity: 0.1 mg

5

Ultrasonic Cleaner

Electroquip

Reagents and Materials

Smt. S. M. Shah Pharmacy College, Amsaran, provided active ingredients of Bisoprolol Fumarate and Telmisartan, and analytical reagents like, HPLC grade-Methanol, Acetonitrile, Phosphate buffer and Water was used throughout the analysis. The Tablet dosage form containing Bisoprolol Fumarate 5 mg and Telmisartan 40 mg was procured from market.

Standard Stock solution preparation

  1. Bisoprolol Fumarate (BIS): Accurately weighed 10 mg of Bisoprolol Fumarate was dissolved into 100 ml Methanol (100 µg/mL).
  2. Telmisartan (TEL): Accurately weighed 80 mg of Telmisartan was dissolved into 100 ml Methanol (800 µg/mL).

Preparation of Sample solution

Take 10 Tablets and weigh the powder equivalent to 5 mg of Bisoprolol Fumarate and 40 mg of Telmisartan in 100 ml volumetric flask and make up the volume with methanol (50 + 400 µg/ml) and then sonicated for 10 minutes and filtered the solution. Pipette out 1 mL from above filtrate solution into the 10 mL volumetric flask and make up the volume with Mobile phase. (5 + 40 µg/mL)

Selection of Detection Wavelength

Analytical wavelength selection was done by the consideration of significant absorbance and from the detailed literature review. Working standards of Bisoprolol Fumarate (5 µg/mL) and Telmisartan (40 µg/mL) were prepared in Mobile phase were scanned in UV between 200 to 400 nm and the observed spectra were overlapped. Wavelength was selected based on significant absorbance.

       
            Overlain UV spectra.png
       
Figure 3: Overlain UV spectra of BIS + TEL (5 + 40 µg/mL) in Mobile phase

Chromatographic conditions

The column used was Hibar ODS C18 column (250 mm × 4.6 mm, 5 µm) under isocratic mode at a flow rate of 1.0 mL/min with UV detection at 230 nm. The mobile phase contained mixture of 10 mM Phosphate buffer: Acetonitrile in the ratio of (30: 70 v/v). The total run time of the method is 15 min, and the injection volume is 20 µL. The final chromatographic conditions of the new method described are summarized in Table 1.

Forced degradation study

Accurately weighed equivalent weight of formulation powder which contains 5 mg Bisoprolol Fumarate + 40 mg Telmisartan and transferred in 100 ml volumetric flask and make up volume till mark with Mobile phase (50 + 400 µg/mL). Allow it to sonicate for 10 minutes and filter by using Whatman filter paper. The filtrate solution is used for Forced degradation study.

RESULTS AND DISCUSSION

Method development and optimization

Stability-indicating RP-HPLC method was developed for quantitative estimation of Bisoprolol Fumarate and Telmisartan in Tablet dosage form. The separation was achieved by using Hibar ODS C18 column (250 mm × 4.6 mm, 5 µm) and 10 mM Phosphate buffer: Acetonitrile (30: 70 v/v) as mobile phase at a flow rate of 1.0 mL/min and detection wavelength was 230 nm. The Rt was found to be 5.715 min for Bisoprolol Fumarate and 3.205 min for Telmisartan.

       
            Chromatogram of BIS.png
       
Figure 4: Chromatogram of BIS + TEL (1 + 8 µg/mL) under Optimized conditions

Table 2: Optimized Chromatographic conditions

Stationary phase

Hibar ODS C18 (250 mm × 4.6 mm, 5 µm)

Pump mode

Isocratic

Mobile phase

Acetonitrile: 10 mM KH2PO4 buffer (70: 30, v/v)

Colum temperature

Ambient

Flow rate

1.0 mL/min

Detection wavelength

230 nm

Injection volume

20 µL

Run time

15 min

Retention time

BIS (5.715 min), TEL (3.205 min)

Diluent

Initial: MeOH

Final: Mobile phase

Method Validation

The validation of method can be performed as per ICH guideline. The parameters assessed were system suitability parameters, specificity, linearity, precision, accuracy, LOD, LOQ and robustness.

System suitability

The system suitability tests were performed using solution of BIS + TEL (1 + 8 µg/mL) and was injected three times with replicates for determination of retention time, symmetry factor, resolution, theoretical plates, and RSD.

Table 3: System suitability parameters

Parameters (n=3)

BIS

RSD

TEL

RSD

Retention time

5.72±0.04

0.66

3.22±0.03

0.80

Tailing factor

1.43±0.01

0.94

1.18±0.01

0.77

Theoretical plates

3825.15±34.23

0.90

3317.24±28.10

0.85

Resolution

3.28±0.03

0.77

Linearity

Linearity test solutions for the assay method were prepared at 5 concentration levels from the of concentration (1+8, 2+16, 3+24, 4+32, and 5+40 µg/mL). The peak areas vs concentration data were evaluated by linear regression analysis.

       
            Calibration curve of BIS for Linearity study.png
       
Figure 5: Calibration curve of BIS for Linearity study

       
            Calibration curve of TEL for Linearity study.png
       
Figure 6: Calibration curve of TEL for Linearity study

       
            Overlain chromatogram of BIS and TEL from Linearity studies.png
       
Figure 7: Overlain chromatogram of BIS and TEL from Linearity studies

Table 4: Linearity data of BIS

 

Sr. no.

Concentration (µg/mL)

1

2

3

4

5

1.

144293

282712

420579

562310

695231

2.

145454

283637

422284

563889

696758

3.

146947

286419

423213

564735

697297

4.

148104

288838

426186

567497

699193

5.

149442

288979

428548

568479

699561

Mean

146848

286117

424162

565382

697608

SD

2048.62

2890.96

3185.87

2556.83

1788.56

%RSD

1.40

1.01

0.75

0.45

0.26

(n=5)

Table 5: Linearity data of TEL

 

Sr. no.

Concentration (µg/mL)

8

16

24

32

40

1.

1190349

2489512

3785601

5032413

6566498

2.

1173165

2456133

3722147

5002478

6542357

3.

1182487

2446856

3741237

5023478

6556743

4.

1204568

2485741

3734121

5051664

6551027

5.

1165984

2431875

3714145

5042416

6548141

Mean

1183311

2462023

3739450

5030490

6552953

SD

15043.59

24959.07

27844.40

18895.14

9178.39

%RSD

1.27

1.01

0.74

0.38

0.14

(n=5)

Precision

The precision of the method was evaluated in terms of repeatability of Bisoprolol Fumarate and Telmisartan test sample preparation and calculating the relative standard deviation (RSD) of the assay (Intraday). Intermediate precision of the method was checked by having another person perform the same procedure on a different day (Interday) under the same experimental conditions.

 

Table 6: Interday and Intraday precision data of BIS

 

Concentration (µg/mL)

Inter-day

Intra-day

Mean ± SD

%

RSD

Mean ± SD

%

RSD

1

147702±1971.43

1.33

143291±1137.95

0.79

3

425782±4007.90

0.94

426499±2563.79

0.60

5

696390±5177.48

0.74

693843±2203.43

0.31

(n=3)

Table 7: Interday and Intraday precision data of TEL

 

Concentration (µg/mL)

Inter-day

Intra-day

Mean ± SD

%

RSD

Mean ± SD

%

RSD

8

1192303±14716.91

1.23

1126929±11547.11

1.02

24

3740180±39414.80

1.05

3765531±25234.24

0.67

40

6550288±59693.97

0.91

6661831±13744.46

0.21

(n=3)

Accuracy

An accuracy study was performed by adding known amounts of Bisoprolol Fumarate and Telmisartan to the sample preparation. The actual and measured concentrations were compared. Recovery of the method was evaluated at 3 different concentration levels (corresponding to 50, 100, and 150% of the test preparation concentration). For each concentration level, 3 sets were prepared and injected in duplicate.

Table 8: Recovery data of BIS and TEL

 

Drug

Level of

Spiking

Amount of

Sample (mg)

Amount spiked

(µg/mL)

Amount

recovered

(µg/mL)

% Mean

Recovery ± SD

BIS

Unspiked

10

-

-

-

50%

10

1

0.98±0.01

98.00±1.00

100%

10

2

1.97±0.02

98.67±0.76

150%

10

3

2.97±0.02

99.00±0.67

TEL

Unspiked

80

-

-

-

50%

80

8

7.93±0.06

99.08±0.75

100%

80

16

15.86±0.07

99.15±0.44

150%

80

24

23.86±0.09

99.43±0.39

(n=3)

Solvent stability

Solvent stability was determined by injecting the same solution at optimized chromatographic condition at 3 different time intervals that is 0 h, 8 h and 24 h. Mixture of Bisoprolol Fumarate + TEL (2 + 16 µg/mL) was injected at optimized chromatographic condition at selected time interval and peak area was observed.

Table 9: Solvent stability data of BIS and TEL

Time (h)

Area

BIS

TEL

0

283667

2427828

8

285708

2438351

24

288359

2441563

LOD and LOQ

LOD and LOQ were determined by two methods,

  1. Visual inspection
  2. Statistical method by utilization of repeatability data

LOD = 3.3 × ?S

 

LOQ = 10 × ?S

 

where,

? = Standard deviation of response

S = Slope of the calibration curve

       
            Figure 8-LOD for BIS.png
       
Figure 8: LOD for BIS + TEL (100 + 800 ng/mL) by Visual inspection

Table 10: LOD and LOQ data of BIS and TEL by Statistical calculation

Drug

LOD (µg/mL)

LOQ (µg/mL)

BIS

0.06

0.19

TEL

0.61

1.85

Robustness

The robustness study was performed to evaluate the influence of small but deliberate variations in the chromatographic conditions. The factors chosen for this study were the flow rate (±0.1 mL/min), mobile phase composition acetonitrile: phosphate buffer (±5 mL, v/v).

Table 11: Robustness data of BIS and TEL

 

Parameters

Level of

Changes

Observation

BIS

TEL

Peak Area

%RSD

Peak Area

%RSD

Flow rate

0.9 mL/min

691162

0.33

6526631

0.39

1.0 mL/min

695231

6566498

1.1 mL/min

695176

6574379

Composition of Mobile Phase

75: 25 v/v

699095

1.08

6588679

1.20

70: 30 v/v

695231

6566498

65: 35 v/v

684613

6442465

Assay

Table 12: Assay data of BIS and TEL Formulation

Drug

BIS

TEL

Amount Taken (µg/mL)

5

40

Amount Found (µg/mL)

4.90±0.03

39.48±0.45

%Assay

98.07±0.51

98.70±1.14

(n=3 determinations at each level)

       
            Chromatogram of Tablet Formulation.png
       
Figure 9: Chromatogram of Tablet Formulation

Forced degradation study

Sample mixture of Bisoprolol Fumarate and Telmisartan were exposed in different conditions and performed the chromatographic analysis of degradants.

  1. Acidic Degradation: Acidic degradation was performed by heating the drug content in 0.1 N HCl at 60°C for 1 h and then the mixture was neutralized.
  2. Alkaline Degradation: Alkaline degradation was performed by heating the drug content in 0.1 N NaOH at 60°C for 1 h and then the mixture was neutralized.
  3. Oxidative Degradation: The oxidation degradation was performed by heating the drug content in 3% (w/v) H2O2 at 60°C for 1 h.
  4. Thermal Degradation: Thermal degradation was performed by heating the solid drug at 60°C for 3 h.

       
            Chromatogram of Treated sample with 0.1 N HCl.png
       
   Figure 10: Chromatogram of Treated sample with 0.1 N HCl (acid hydrolysis)

       
            Chromatogram of Treated sample with 0.1 N NaOH.png
       
Figure 11: Chromatogram of Treated sample with 0.1 N NaOH (base hydrolysis)

       
            Chromatogram of Treated sample with 3%.png
       
Figure 12: Chromatogram of Treated sample with 3% (w/v) H2O2 (oxidative degradation)

Table 13: Summary of Forced degradation study

 

Stress condition

Type of sample

Area

?gradation

BIS

TEL

BIS

TEL

Acid hydrolysis

Control

423154

4311384

14.28

14.92

Treated

362728

3668341

Base hydrolysis

Control

427101

4478825

13.82

14.18

Treated

368064

3843679

Oxidative degradation

Control

503581

5582653

11.22

11.75

Treated

447103

4926537

Thermal degradation

Standard

699561

6548141

10.27

10.94

Treated

627715

5831531

Control= Sample prepared without imposing to stress conditions

Treated= Sample prepared with stress conditions

Table 14: Summary of validation parameters

Parameter

Result

BIS

TEL

Linearity and

Range

0.999

(1-5 µg/mL)

0.999

(8-40 µg/mL)

Repeatability (RSD)

1.40-0.26

1.27-0.14

Interday precision (RSD)

1.33-0.74

1.23-0.91

Intraday precision (RSD)

0.79-0.31

1.02-0.21

%Recovery

99.00-98.00

98.08-99.43

Specificity

Specific

Specific

Sensitivity

Sensitive

Sensitive

Robustness

Robust

Robust

CONCLUSIONS

In this research, a new, simple, precise, accurate, and robust stability indicating RP-HPLC method was developed for quantification of Bisoprolol Fumarate and Telmisartan in combined marketed tablet formulation. The proposed method is capable to separate and quantify the components from their combination. The proposed was able to detect the degradants of both drugs. Results of the validation parameters and assay were in an acceptable range. Hence, it can be employed in routine assay of Bisoprolol Fumarate and Telmisartan in combined formulation.

ACKNOWLEDGMENTS

The authors are thankful to the management of Smt. S. M. Shah Pharmacy College, Amsaran, Mahemdabad, Gujarat, India, for providing standard sample of drugs and, all the necessary facilities, and Pinak Patel, Professor, Smt. S. M. Shah Pharmacy College, Amsaran, Mahemdabad for their valuable guidance and constant support to carry out the research work.

Funding

The research was conducted without any funding sources.

Conflict Of Interest

All authors declare no conflict of interest.

REFERENCES

  1. Snehal P, Ashpak T, Sunil M, Shubhada P: Simultaneous Determination of Bisoprolol Fumarate and Telmisartan by Area under Curve UV Spectrophotometric Method. Int. J. Pharm. Pharma. Res. 2020; 18(2):147-156.
  2. Sattar OI, Abuseada HH, Ramzy S, Abuelwafa MM: Three spectrophotometric quantitative analysis of bisoprolol fumarate and telmisartan in fixed-dose combination utilizing ratio spectra manipulation methods. Scientific Reports 2024; 14(1):22899.
  3. Barge VU, Gaikwad RB, Chaudhari FM, Kande T: Development and Validation of Analytical Method for Simultaneous Estimation of Bisoprolol Fumarate and Telmisartan by Using RP HPLC Method. Int. J. Pharm. Clinical Res. 2018; 10(8):219-23.
  4. Shivani R, Dhopate, LR, Gandhi, NS Bhajipale: Development and Validation Of RP-HPLC Method For Simultaneous Estimation of Bisoprolol Fumarate and Telmisartan in Pharmaceutical Formulation. Int. J. Res. Ana. Rev. 2022; 9(2):178-186.
  5. Chaudhari AR, Raut MA, Gabhane KB, Salode VL, Barde LN: Development and Validation Of RP-HPLC Method For Simultaneous Estimation of Bisoprolol Fumarate and Telmisartan in Bulk and Pharmaceutical Formulation. Journal of Emerging Technologies and Innovative Research 2022; 9(8): 766-774.
  6. Snehal P, Ashpak T, Sunil M, Shubhada P: Development and validation of RP-HPLC method for the simultaneous estimation of bisoprolol fumarate and telmisartan from pharmaceutical formulations. Int. J. Pharm. Ana. Res. 2020; 9(2):129-136.
  7. Gunjal S, Jain H, Sankaran S, Yadav S: High-performance thin-layer chromatography-based methodology for simultaneous estimation of bisoprolol fumarate and telmisartan. JPC–Journal of Planar Chromatography–Modern TLC 2024; 37(2):161-8.
  8. Bhavsar A, Tandel D, Patel K, Parmar R, Patel G, Gandhi T: DoE assisted, stability indicating HPTLC method development and validation for concurrent determination of Telmisartan and Bisoprolol fumarate in tablet dosage form. Essential Chem 2025; 2(1):1-6.
  9. Chauhan A, Bharti MB, Chauhan P: Analytical Method Development and Validation: A Concise Review. J. Anal. Bioanal. Tech. 2015; 6(1):1-5.
  10. Doltade M, Saudagar R: Analytical Method Development and Validation: A Review. J. Drug Delivery Thera. 2019; 9(3):563-570.
  11. Mr. Gorhe S G, Miss. Pawar G R: A Review on High Performance Liquid Chromatography (HPLC). Int. J. of Adv. Sci. Res. Eng. Trends 2018; 3(1):5-9.
  12. Manjiri S, Dr. Satish K, Dr. Arunabha M, Dr. N Jyothi: A Review on HPLC Method Development and Validation. EPRA Int. J. Res. Development 2021; 6(10):92-96.
  13. Yadav V and Bharkatiya M: A Review on HPLC Method Development and Validation. Res. J. Life Sci. 2017; 2(6):166-178.
  14. Pallavi NP: HPLC Method Development - A Review. J. Pharm. Res. Edu. 2017; 2(1):243-260.
  15. Blessy M: Development of forced degradation and stability indicating studies of drugs-A review. J. Pharm. Anal. 2014; 4:159- 165.
  16. Brummer DH: How to approach a forced degradation study. Life Sci Tech Bull 2011; 31:1-4.
  17. Iram F: Forced Degradation Studies. J. Anal. Pharm. Res. 2016 3:73.
  18. Klick S, Muijselaar PG, Waterval J, Eichinger T, Korn C, et al.: Toward a Generic Approach for Stress Testing of Drug Substances and Drug Products. Pharm. Tech. 2000; 29(2):48-57.
  19. ICH Q2A Text on validation of analytical procedure, International conference on harmonization. Tripartite guideline 1994; 1-5.
  20. ICH Q2B Validation of analytical procedure: methodology, International conference on harmonization. Tripartite guideline 1994; 1-10.

Reference

  1. Snehal P, Ashpak T, Sunil M, Shubhada P: Simultaneous Determination of Bisoprolol Fumarate and Telmisartan by Area under Curve UV Spectrophotometric Method. Int. J. Pharm. Pharma. Res. 2020; 18(2):147-156.
  2. Sattar OI, Abuseada HH, Ramzy S, Abuelwafa MM: Three spectrophotometric quantitative analysis of bisoprolol fumarate and telmisartan in fixed-dose combination utilizing ratio spectra manipulation methods. Scientific Reports 2024; 14(1):22899.
  3. Barge VU, Gaikwad RB, Chaudhari FM, Kande T: Development and Validation of Analytical Method for Simultaneous Estimation of Bisoprolol Fumarate and Telmisartan by Using RP HPLC Method. Int. J. Pharm. Clinical Res. 2018; 10(8):219-23.
  4. Shivani R, Dhopate, LR, Gandhi, NS Bhajipale: Development and Validation Of RP-HPLC Method For Simultaneous Estimation of Bisoprolol Fumarate and Telmisartan in Pharmaceutical Formulation. Int. J. Res. Ana. Rev. 2022; 9(2):178-186.
  5. Chaudhari AR, Raut MA, Gabhane KB, Salode VL, Barde LN: Development and Validation Of RP-HPLC Method For Simultaneous Estimation of Bisoprolol Fumarate and Telmisartan in Bulk and Pharmaceutical Formulation. Journal of Emerging Technologies and Innovative Research 2022; 9(8): 766-774.
  6. Snehal P, Ashpak T, Sunil M, Shubhada P: Development and validation of RP-HPLC method for the simultaneous estimation of bisoprolol fumarate and telmisartan from pharmaceutical formulations. Int. J. Pharm. Ana. Res. 2020; 9(2):129-136.
  7. Gunjal S, Jain H, Sankaran S, Yadav S: High-performance thin-layer chromatography-based methodology for simultaneous estimation of bisoprolol fumarate and telmisartan. JPC–Journal of Planar Chromatography–Modern TLC 2024; 37(2):161-8.
  8. Bhavsar A, Tandel D, Patel K, Parmar R, Patel G, Gandhi T: DoE assisted, stability indicating HPTLC method development and validation for concurrent determination of Telmisartan and Bisoprolol fumarate in tablet dosage form. Essential Chem 2025; 2(1):1-6.
  9. Chauhan A, Bharti MB, Chauhan P: Analytical Method Development and Validation: A Concise Review. J. Anal. Bioanal. Tech. 2015; 6(1):1-5.
  10. Doltade M, Saudagar R: Analytical Method Development and Validation: A Review. J. Drug Delivery Thera. 2019; 9(3):563-570.
  11. Mr. Gorhe S G, Miss. Pawar G R: A Review on High Performance Liquid Chromatography (HPLC). Int. J. of Adv. Sci. Res. Eng. Trends 2018; 3(1):5-9.
  12. Manjiri S, Dr. Satish K, Dr. Arunabha M, Dr. N Jyothi: A Review on HPLC Method Development and Validation. EPRA Int. J. Res. Development 2021; 6(10):92-96.
  13. Yadav V and Bharkatiya M: A Review on HPLC Method Development and Validation. Res. J. Life Sci. 2017; 2(6):166-178.
  14. Pallavi NP: HPLC Method Development - A Review. J. Pharm. Res. Edu. 2017; 2(1):243-260.
  15. Blessy M: Development of forced degradation and stability indicating studies of drugs-A review. J. Pharm. Anal. 2014; 4:159- 165.
  16. Brummer DH: How to approach a forced degradation study. Life Sci Tech Bull 2011; 31:1-4.
  17. Iram F: Forced Degradation Studies. J. Anal. Pharm. Res. 2016 3:73.
  18. Klick S, Muijselaar PG, Waterval J, Eichinger T, Korn C, et al.: Toward a Generic Approach for Stress Testing of Drug Substances and Drug Products. Pharm. Tech. 2000; 29(2):48-57.
  19. ICH Q2A Text on validation of analytical procedure, International conference on harmonization. Tripartite guideline 1994; 1-5.
  20. ICH Q2B Validation of analytical procedure: methodology, International conference on harmonization. Tripartite guideline 1994; 1-10.

Photo
Mudra Solanki
Corresponding author

Department of Pharmaceutical Quality Assurance, Smt. S. M. Shah Pharmacy College, Mahemdabad, Gujarat

Photo
Pinak Patel
Co-author

Department of Pharmaceutical Quality Assurance, Smt. S. M. Shah Pharmacy College, Mahemdabad, Gujarat

Photo
Shivani Jani
Co-author

Department of Pharmaceutical Quality Assurance, Smt. S. M. Shah Pharmacy College, Mahemdabad, Gujarat

Photo
Rashmi Shukla
Co-author

Department of Pharmaceutical Quality Assurance, Smt. S. M. Shah Pharmacy College, Mahemdabad, Gujarat

Photo
Krunal Detholia
Co-author

Department of Pharmaceutics, Smt. S. M. Shah Pharmacy College, Mahemdabad, Gujarat

Mudra Solanki*, Pinak Patel, Shivani Jani, Rashmi Shukla, Krunal Detholia, Development And Validation of Stability Indicating RP-HPLC Method For Quantification of Bisoprolol Fumarate and Telmisartan in Tablet Dosage Form, Int. J. of Pharm. Sci., 2025, Vol 3, Issue 1, 1839-1849. https://doi.org/10.5281/zenodo.14716102

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