Authors: Shivani Jani, Rashmi Shukla, Pinak Patel, Binny Mehta, Krunal Detholia
Current research paper describes highly specific and reproducible 1 order derivative spectroscopic method for quantitative analysis of Sitagliptin which is a DPP4 inhibitors and Dapagliflozin which is SGLT2 inhibitors from its synthetic mixture. Both drugs are from Anti Diabetics class. Present analytical method was developed on Shimadzu double beam spectrophotometer equipped with UV probe 2.42 as software using methyl alcohol as solvent. Quantification of Sitagliptin was carried out at zero cross over point of Dapagliflozin that is 275 nm and for Dapagliflozin, it was achieved at 232 nm which is zero cross over point of Sitagliptin. Method shows linear response in the range of 25-125 µg/mL of Sitagliptin and 2.5-12.5 µg/mL of Dapagliflozin. Method was found to be accurate with recovery between 99.3 – 100.1 % for Sitagliptin and 98.2 – 100.7 % for Dapagliflozin. The developed method was validated as per ICH Q2 R1 guidelines and was successfully applied for quantitative analysis of synthetic mixture of Sitagliptin and Dapagliflozin. Keywords: Sitagliptin, Dapagliflozin, Derivative spectroscopy, Zero crossover point, Analytical method validation
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