Development and Validation of Simultaneous Equation Method for Estimation of Sitagliptin and Saxagliptin in Combined Pharmaceutical Dosage Form by Using UV Spectrophotometric Method

Authors

  • Dharmvir Singh Department of Quality Assurance, Faculty of Pharmacy, Oriental University Indore-India
  • Neetesh Kumar Jain Department of Pharmacology, Faculty of Pharmacy, Oriental University Indore-India
  • Apoorva Tiwari Department of Quality Assurance, Faculty of Pharmacy, Oriental University Indore-India
  • Neelam Khan Department of Quality Assurance, Faculty of Pharmacy, Oriental University Indore-India

DOI:

https://doi.org/10.22270/ijmspr.v8i2.43

Keywords:

Sitagliptin, Saxagliptin, Anti-diabetic, UV spectrophotometric Methods, Method validation

Abstract

Day by day the number of drug groups also the numbers of drugs within these groups for treatment of diabetes are increasing rapidly. The numbers of newer anti-diabetic formulations either in single or in combined dosage forms are marketed and investigated, sitagliptin with saxagliptin are not official in any pharmacopoeia. the aim of the present work was to develop and validate newer analytical methods like UV spectrophotometric methods, which should be applied for the further analysis of anti-diabetic drugs in bulk drugs and its pharmaceutical formulations. To develop and validate simultaneous equation method for simultaneous estimation of sitagliptin and saxagliptin in combined pharmaceutical dosage form by UV spectrophotometric method.

Keywords: Sitagliptin, Saxagliptin, Anti-diabetic, UV spectrophotometric Methods, Method validation

Author Biographies

Dharmvir Singh , Department of Quality Assurance, Faculty of Pharmacy, Oriental University Indore-India

Department of Quality Assurance, Faculty of Pharmacy, Oriental University Indore-India

Neetesh Kumar Jain, Department of Pharmacology, Faculty of Pharmacy, Oriental University Indore-India

Department of Pharmacology, Faculty of Pharmacy, Oriental University Indore-India

Apoorva Tiwari, Department of Quality Assurance, Faculty of Pharmacy, Oriental University Indore-India

Department of Quality Assurance, Faculty of Pharmacy, Oriental University Indore-India

Neelam Khan, Department of Quality Assurance, Faculty of Pharmacy, Oriental University Indore-India

Department of Quality Assurance, Faculty of Pharmacy, Oriental University Indore-India

References

Hardman J. G., Limbird L. E. and Gilman A. G. Goodman and Gilman’s the Pharmacological Basis of Therapeutics. Mc Graw Hill Publishing Division. 2001; 10:1541-1562.

https://en.wikipedia.org/wiki/Diabetes_mellitus

Harvey R. A., Champe P. C., Howland R. D. and Mycek M. J. Lippincott’s Illustrated Reviews: Pharmacology. Lippincott Williams and Wilkins. 2006; 3:281-293.

https://en.wikipedia.org/wiki/Anti-diabetic_medication

Guidance for Industry. Analytical Procedure and Method Validation Chemistry, Manufacturing and Controls Documentation. Rockville, Maryland: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) and Center for Veterinary Medicine (CVM). 2004

United States Pharmacopoeia. Rockville, MD: US Pharmacopoeial Convention Inc. 2003; 26:1151.

ICH Guideline Q2 (R1). Validation of Analytical Procedures: Text and Methodology. Geneva: 1996

WHO TRS 937,40th report, Appendix 4, Analytical Method Validation, 2006, 136-140.

Skoog D. A., Holler F. J. and Nieman T. A. Principle of Instrumentation Analysis. Thomas Asia Pvt. Ltd., 2005;5:580.

Rawat T. and Pandey I. P. Forced Degradation Studies for Drug Substances and Drug Products- Scientific and Regulatory Considerations. J. Pharm. Sci. Res. 2015; 7(5):238- 241.

Singh R. and Rehman Z. Current Trends in Forced Degradation Study for Pharmaceutical Product Development. J. Pharm. Edu. Res. 2012; 2:54-63.

Blessy M., Patel R. D., Prajapati P. N. and Agrawal Y. K. Development of Forced Degradation and Stability Indicating Studies of Drugs-A Review. J. Pharma. Anal. 2014; 4(3):159-165. https://doi.org/10.1016/j.jpha.2013.09.003

Konari S. N., Jacob J. T. and Prakash V. Stability Indicating UV Spectrophotometric Method for Linagliptin and Metformin in Pharmaceutical Dosage Form. Pharm. Meth. 2017; 8(2):121-126. https://doi.org/10.5530/phm.2017.8.19

Pokharana M, Vaishnav R, Goyal A, Shrivastava A, Stability testing guidelines of pharmaceutical products, Journal of Drug Delivery and Therapeutics 2018; 8(2):169-175

Ahir K. B., Patelia E. M. and Shah A. Simultaneous Estimation of Metformin Hydrochloride and Repaglinide in Pharmaceutical Formulation by HPTLC- Densitometry Method. J. Chromat. Sep. Tech. 2013; 4(1):1-5.

Shirode A. R., Maduskar P. D., Deodhar M. S. and Kadam V. J. RP-HPLC and HPTLC Methods for Simultaneous Estimation of Metformin Hydrochloride and Vildagliptin From Bulk and Marketed Formulation: Development and Validation. British J. Pharm. Res. 2014; 4(20):2370-2386. https://doi.org/10.9734/BJPR/2014/12820

Rajasekaran A., Kavitha and Arivukkarasu R. Development and Validation of HPTLC Method for Simultaneous Estimation and Stability Indicating Study of Metformin HCl and Linagliptin in Pharmaceutical Formulation. World J. Pharm. Sci. 2014; 2(4):317- 327.

Tejpal, Parle A. and Sharma K. Development and Validation of HPTLC Method for Simultaneous Estimation of Metformin Hydrochloride and Alogliptin Benzoate in Bulk Drugs and Combined Dosage Forms. J. Pharm. Care Health Sys. 2015; 2(5):116.

Published

15-06-2022

How to Cite

Singh , D. ., Jain, N. K. ., Tiwari, A. ., & Khan, N. . (2022). Development and Validation of Simultaneous Equation Method for Estimation of Sitagliptin and Saxagliptin in Combined Pharmaceutical Dosage Form by Using UV Spectrophotometric Method. International Journal of Medical Sciences and Pharma Research, 8(2), 83–90. https://doi.org/10.22270/ijmspr.v8i2.43

Most read articles by the same author(s)

1 2 > >>