Method Development and Validation of RP-HPLC method for Saxagliptin and Sitagliptin in Pharmaceutical Dosage Form - A Review

Suma A.H (1) , Binoy Varghese Cheriyan (2) , Vijey Aanandhi M (3) , Ramachandran S (4)
(1) Department of Pharmaceutical Chemistry and Analysis, Vels Institute of science technology and Advanced Studies, Pallavarm, Chennai – 600 117, Tamil Nadu, India, India ,
(2) Department of Pharmaceutical Chemistry and Analysis, Vels Institute of science technology and Advanced Studies, Pallavarm, Chennai – 600 117, Tamil Nadu, India, India ,
(3) Department of Pharmaceutical Chemistry and Analysis, Vels Institute of science technology and Advanced Studies, Pallavarm, Chennai – 600 117, Tamil Nadu, India, India ,
(4) Department of Pharmaceutical Chemistry and Analysis, Vels Institute of science technology and Advanced Studies, Pallavarm, Chennai – 600 117, Tamil Nadu, India, India

Abstract

The study's goal was to develop a plain, quick, and responsive RP-HPLC method for determining the concentrations of Saxagliptin and Sitagliptin in pharmaceutical bulk dosage form (bulk powders). Isocratic elution with Cosmosil C18 (250nm 4.6nm, 5m particle size) and UV detection at 212nm for Saxagliptin and Develosil ODS HG-5 RP-C18 (15cm 4.6mm, 5m particle size) and UV detection at 255nm for Sitagliptin were used in this chromatographic process. Methanol and water (70:30) in a mobile solution with a flow rate of 0.8ml/min for Saxagliptin and (0.05m) phosphate buffer: methanol and water (70:30) in a mobile solution with a flow rate of 0.8ml/min for Saxagliptin and (0.05m) phosphate buffer: These protocols have been put through their paces in accordance with ICH guidelines. The normal curves for Saxagliptin and Sitagliptin were observed to have a linear relationship across the analytical ranges of 10-50 g/ml and 30-70 g/ml, respectively. The accuracy, precision, limit of identification, the limit of quantification, and robustness of the system were all calculated. Various analytical methods such as UPLC (Ultra performance liquid chromatography), UV spectroscopy, LC-UV methods have performed to the quantitative determination of Saxagliptin and Sitagliptin drugs.

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Authors

Suma A.H
Binoy Varghese Cheriyan
Vijey Aanandhi M
Ramachandran S
ramachandrans.sps@velsuniv.ac.in (Primary Contact)
Suma A.H, Binoy Varghese Cheriyan, Vijey Aanandhi M, & Ramachandran S. (2021). Method Development and Validation of RP-HPLC method for Saxagliptin and Sitagliptin in Pharmaceutical Dosage Form - A Review. International Journal of Research in Pharmaceutical Sciences, 12(2), 1338–1344. Retrieved from https://ijrps.com/home/article/view/189

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