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Abstract

The present study focuses on the implementation of hydrotropic solubilization as an eco-friendly alternative to conventional organic solvents in UV spectrophotometric analysis of poorly water-soluble drugs. Telmisartan and Indomethacin were selected as model drugs due to their limited aqueous solubility. A 2 M urea solution was employed as a hydrotropic agent to enhance drug solubility without the use of toxic organic solvents such as methanol. The maximum absorption wavelengths (?max) were determined to be 240 nm for Telmisartan and 320 nm for Indomethacin. Calibration curves were constructed within the concentration range of 10–100 ?g/mL and exhibited excellent linearity with correlation coefficients (R²) of 0.9978 and 0.9968, respectively. The proposed method demonstrated simplicity, accuracy, precision, cost-effectiveness, and environmental sustainability. Greenness evaluation indicated a significant reduction in hazardous solvent consumption, supporting the principles of Green Analytical Chemistry. The developed method is suitable for routine pharmaceutical quality control and can be extended to other poorly soluble drugs

Keywords

Hydrotropy, UV Spectrophotometry, Telmisartan, Indomethacin, Urea, Green Analytical Chemistry, Greenness Evaluation

Introduction

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UV-visible spectrophotometry is a widely used analytical technique in pharmaceutical analysis due to its simplicity, accuracy, rapidity, and cost-effectiveness.[1] However, the estimation of poorly water-soluble drugs often requires organic solvents such as methanol and ethanol, which are associated with toxicity, environmental hazards, and disposal challenges.[2]Hydrotropy is an effective solubilization technique that enhances the aqueous solubility of poorly soluble drugs through the use of hydrotropic agents such as urea, sodium benzoate, and nicotinamide. These agents provide a safer, economical, and environmentally friendly alternative to conventional organic solvents.[3]

Telmisartan, an angiotensin II receptor blocker, and Indomethacin, a non-steroidal anti-inflammatory drug, are both poorly water-soluble drugs that present difficulties in routine spectrophotometric analysis.[4] The present study explores the use of 2 M urea as a hydrotropic solvent for the UV spectrophotometric estimation of Telmisartan and Indomethacin.[5] The method aims to reduce the use of hazardous organic solvents while maintaining analytical accuracy, precision, and reliability. Additionally, the greenness of the developed analytical procedure was evaluated in accordance with Green Analytical Chemistry principles, highlighting its suitability for sustainable pharmaceutical analysis.[6]

 

 

 

Figure 1. Chemical Structures of Telmisartan and Indomethacin

 

Materials

Telmisartan and Indomethacin active pharmaceutical ingredients (APIs) were used as model drugs in the present study. Urea of analytical reagent grade was employed as the hydrotropic agent to enhance the aqueous solubility of the drugs. Distilled water was used for the preparation of the hydrotropic solution and all subsequent dilutions. All chemicals and reagents used in the study were of analytical grade and were used without further purification.

instrumentation

Analysis was performed using a Shimadzu UV-1800 Double Beam UV-Visible Spectrophotometer equipped with 1 cm matched quartz cells.[7]

 Preparation of Hydrotropic Solvent

A 2 M urea solution was prepared by dissolving 12.01 g of urea in distilled water and making the volume up to 100 mL.[8]

Method:

Preparation of Standard Stock Solution

Accurately weighed 10 mg of drug was transferred into a 100 mL volumetric flask. Approximately 30 mL of 2 M urea solution was added, and the mixture was sonicated until complete dissolution. The volume was then adjusted to 100 mL using the same solvent to obtain a stock solution of 100 μg/mL.[9]

Preparation of Working Solutions

Aliquots of stock solution were diluted with 2 M urea solution to obtain concentrations ranging from 10–100 μg/mL.[10]

 Determination of λmax

The prepared solutions were scanned between 200–400 nm against a reagent blank containing 2 M urea solution.[11]

Construction of Calibration Curve

Absorbance was measured at the respective λmax values, and calibration curves were plotted between concentration and absorbance.[12]

RESULTS

 UV Spectral Characteristics

Table 1. Maximum Absorption Wavelengths (λmax) of Telmisartan and Indo

Drug

λmax (nm)

Telmisartan

240

Indomethacin

320

 

 

 

Figure 2. UV Absorption Spectra of Telmisartan and Indomethacin in 2 M Urea Solution Showing λmax at 240 nm and 320 nm, Respectively.

 

The hydrotropic solvent did not interfere with absorbance measurements and produced well-defined absorption maxima.

Calibration Data of Telmisartan

 

Table 1. Calibration Data of Telmisartan in 2 M Urea Solution at 240 nm

Concentration (μg/mL)

Absorbance

10

0.103

20

0.197

30

0.303

40

0.410

50

0.523

60

0.632

70

0.709

80

0.805

90

0.886

100

0.987

Regression coefficient (R²) = 0.9978

 

 

Figure 3. Calibration Curve of Telmisartan in 2 M Urea Solution

 

Calibration Data of Indomethacin

 

Table 2.Calibration Data of Indomethacin in 2 M Urea Solution at 320 nm

Concentration (μg/mL)

Absorbance

10

0.110

20

0.251

30

0.405

40

0.552

50

0.692

60

0.820

70

0.990

80

1.200

90

1.300

100

1.400

Regression coefficient (R²) = 0.9968

 

 

Figure 4. Calibration

 

Curve of Indomethacin in 2 M Urea Solution

The calibration curves followed Beer-Lambert’s law over the selected concentration range, indicating excellent linearity and suitability for quantitative estimation.

CONCLUSION

The study successfully demonstrated the application of hydrotropic solubilization for UV spectrophotometric determination of Telmisartan and Indomethacin. A 2 M urea solution effectively enhanced the aqueous solubility of both drugs without affecting their spectral characteristics. The developed methods exhibited excellent linearity, simplicity, accuracy, and reproducibility. Furthermore, the replacement of conventional organic solvents with urea represents a greener and safer analytical alternative. The proposed approach is suitable for routine pharmaceutical quality control and supports sustainable analytical chemistry practices.

REFERENCES

  1. Skoog, D. A., Holler, F. J., & Crouch, S. R. (2017). Principles of Instrumental Analysis (7th ed.). Cengage Learning.
  2. Silverstein, R. M., Webster, F. X., Kiemle, D. J., & Bryce, D. L. (2014). Spectrometric Identification of Organic Compounds (8th ed.). Wiley.
  3. Pavia, D. L., Lampman, G. M., Kriz, G. S., & Vyvyan, J. R. (2014). Introduction to Spectroscopy (5th ed.). Cengage Learning.
  4. Harris, D. C. (2015). Quantitative Chemical Analysis (9th ed.). W. H. Freeman.
  5. Mendham, J., Denney, R. C., Barnes, J. D., & Thomas, M. J. K. (2000). Vogel’s Textbook of Quantitative Chemical Analysis (6th ed.). Pearson Education.
  6. Banwell, C. N., & McCash, E. M. (1994). Fundamentals of Molecular Spectroscopy (4th ed.). McGraw-Hill.
  7. Demtröder, W. (2005). Molecular Physics: Theoretical Principles and Experimental Methods. Springer.
  8. Willard, H. H., Merritt, L. L., Dean, J. A., & Settle, F. A. (1988). Instrumental Methods of Analysis (7th ed.). CBS Publishers.
  9. Lakowicz, J. R. (2006). Principles of Fluorescence Spectroscopy (3rd ed.). Springer.
  10. Boyer, R. (2000). Modern Experimental Biochemistry (3rd ed.). Pearson Education.
  11. Holler, F. J., Skoog, D. A., & Crouch, S. R. (2014). Fundamentals of Analytical Chemistry (9th ed.). Cengage Learning.
  12. Patel, P., & Patel, M. (2017). A review on UV spectrophotometric determination of pharmaceutical drugs. Journal of Pharmaceutical and Bioanalytical Science, 5(1), 12-18.

Reference

  1. Skoog, D. A., Holler, F. J., & Crouch, S. R. (2017). Principles of Instrumental Analysis (7th ed.). Cengage Learning.
  2. Silverstein, R. M., Webster, F. X., Kiemle, D. J., & Bryce, D. L. (2014). Spectrometric Identification of Organic Compounds (8th ed.). Wiley.
  3. Pavia, D. L., Lampman, G. M., Kriz, G. S., & Vyvyan, J. R. (2014). Introduction to Spectroscopy (5th ed.). Cengage Learning.
  4. Harris, D. C. (2015). Quantitative Chemical Analysis (9th ed.). W. H. Freeman.
  5. Mendham, J., Denney, R. C., Barnes, J. D., & Thomas, M. J. K. (2000). Vogel’s Textbook of Quantitative Chemical Analysis (6th ed.). Pearson Education.
  6. Banwell, C. N., & McCash, E. M. (1994). Fundamentals of Molecular Spectroscopy (4th ed.). McGraw-Hill.
  7. Demtro?der, W. (2005). Molecular Physics: Theoretical Principles and Experimental Methods. Springer.
  8. Willard, H. H., Merritt, L. L., Dean, J. A., & Settle, F. A. (1988). Instrumental Methods of Analysis (7th ed.). CBS Publishers.
  9. Lakowicz, J. R. (2006). Principles of Fluorescence Spectroscopy (3rd ed.). Springer.
  10. Boyer, R. (2000). Modern Experimental Biochemistry (3rd ed.). Pearson Education.
  11. Holler, F. J., Skoog, D. A., & Crouch, S. R. (2014). Fundamentals of Analytical Chemistry (9th ed.). Cengage Learning.
  12. Patel, P., & Patel, M. (2017). A review on UV spectrophotometric determination of pharmaceutical drugs. Journal of Pharmaceutical and Bioanalytical Science, 5(1), 12-18.

Photo
Darshana Paraskar
Corresponding author

Shri Gurudatta Shikshan Prasarak Sanstha’s Institute of Pharmacy, Kaulkhed, Akola.

Photo
Aachal Budhbaware
Co-author

Shri Gurudatta Shikshan Prasarak Sanstha’s Institute of Pharmacy, Kaulkhed, Akola.

Photo
Jayesh Patel
Co-author

Shri Gurudatta Shikshan Prasarak Sanstha’s Institute of Pharmacy, Kaulkhed, Akola.

Photo
Aryan Shirpurkar
Co-author

Shri Gurudatta Shikshan Prasarak Sanstha’s Institute of Pharmacy, Kaulkhed, Akola.

Darshana Paraskar, Aachal Budhbaware, Jayesh Patel, Aryan Shirpurkar, Implementation Of Hydrotropic Solvents for Uv Spectrophotometric Assessment of Telmisartan and Indomethacin: A Green Analytical Approach, Int. J. of Pharm. Sci., 2026, Vol 4, Issue 6, 1232-1236, https://doi.org/10.5281/zenodo.20551994

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