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Research Article

Quantitative Computation of Synthetic Mixture Comprising Sitagliptin and Dapagliflozin from Synthetic Mixture by Vierdot’s Method

Pinak Patel*, Yesha Patel, Shivani Jani and Krunal Detholia

Corresponding Author: Pinak Patel, Department of Pharmaceutical Quality Assurance, Smt. S.M. Shah Pharmacy College, Amsaran, Gujarat, India.

Received: April 29, 2022 ;    Revised: May 3, 2022 ;    Accepted: May 6, 2022 ;   Available Online: May 20, 2022

Citation: Patel P, Patel Y, Jani S & Detholia K. (2022) Quantitative Computation of Synthetic Mixture Comprising Sitagliptin and Dapagliflozin from Synthetic Mixture by Vierdot’s Method. J Pharm Sci Drug Discov, 1(2):1-5.

Copyrights: ©2022 Patel P, Patel Y, Jani S & Detholia K. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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Abstract

Current research paper describes highly specific, reproducible and efficient Vierdot’s method also known as simultaneous equation method for quantitative computation of synthetic mixture comprising Sitagliptin which is a DPP4 inhibitor and Dapagliflozin which is SGLT2 inhibitor. Both active components belong to the therapeutic class of anti-diabetics. Present UV spectrophotometric method was developed on Shimadzu double beam spectrophotometer equipped with UV probe 2.42 as software using methyl alcohol as solvent. As per the requirements of Vierdot’s method, 224 nm and 267 nm was selected as analytical wavelength for quantification of Sitagliptin and Dapagliflozin which is their respective λmax. Method showed linear response in the range of 50-150 µg/mL of Sitagliptin and 5-15 µg/mL of Dapagliflozin. The main requirement of having glen ration outside the range of 0.1-2.0 was also satisfied at each concentration level. Method was found to be accurate with recovery between 96.8 - 98.2 % for Sitagliptin and 99.6 - 100.8 % for Dapagliflozin. The developed method was validated as per ICHQ2R1 guidelines and was successfully applied for quantitative analysis of synthetic mixture of Sitagliptin and Dapagliflozin.

Keywords: Sitagliptin, Dapagliflozin, Simultaneous equation method, Glen ratio, Analytical method validation

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