International Journal of Pharmaceutical Chemistry and Analysis 2022;9(1):28–34 Content available at: https://www.ipinnovative.com/open-access-journals International Journal of Pharmaceutical Chemistry and Analysis Journal homepage: https://www.ijpca.org/ Original Research Article Quantitative estimation of sitagliptin and dapagliflozin propanediol monohydrate in synthetic mixture using 1 st order derivative spectroscopy simultaneous spectrophotometric analysis Shivani Jani 1, *, Rashmi Shukla 1 , Pinak Patel 1 , Binny Mehta 1 , Krunal Detholia 2 1 Dept. of Pharmaceutical Quality Assurance, Smt. S. M. Shah Pharmacy College, Ahmedabad, Gujarat, India 2 Dept. of Pharmaceutics, Smt. S. M. Shah Pharmacy College, Gujarat, India ARTICLE INFO Article history: Received 02-03-2022 Accepted 15-03-2022 Available online 09-04-2022 Keywords: Sitagliptin Dapagliflozin Derivative spectroscopy Zero crossover point Analytical method validation ABSTRACT Current research paper describes highly specific and reproducible 1 st 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. This is an Open Access (OA) journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms. For reprints contact: reprint@ipinnovative.com 1. Introduction Sitagliptin (SITA) acting as Anti Diabetic agent (Dipeptidyl peptidase-4 inhibitor) which boosts post prandial insulin release, decrease Glucagon secretion and lower mean time as well as fasting blood glucose in type 2 diabetes. 1 This agent is used in combination with other oral hypoglycemic agents. Dapagliflozin (DAPA) acting as Sodium-Glucose cotransporter-2(SGLT2) inhibitors. This agent is used in combination with diet and exercise to improve glycemic control in adult with type -2 Diabetes. SGLT 2 is major transporter of glucose whose inhibition induces glucosuria and lower blood sugar in type 2 diabetes mellitus. 2 According to the clinical trial study of real- * Corresponding author. E-mail address: janishivani79@gmail.com (S. Jani). World Evidence with SGLT2i(DAPA) and DPP4i (SITA) in Type-2 Diabetes patients in Spain (NCT04149067)it shows beneficial positive effect on patient of Diabetes Mellitus (Type-2) at the close level of 5-10 mg of DAPA and 50- 100 mg of SITA. 3 Best clinical effectiveness was observed at 100 mg dose of SITA and 10 mg of DAPA and hence for method development purpose dose was selected as a mixture comprising 10 mg of DAPA and 100 mg of SITA. Several analytical methods are available which can determine SITA and DAPA individually or in combination with another drug. From detailed review of literature, it was found that no analytical method is available for determination of DAPA and SITA from simulated mixture or formulation, 4–24 Furthermore UV spectrophotometric methods are more convenient with respect to operation in comparison with chromatographic methods of analysis. In https://doi.org/10.18231/j.ijpca.2022.005 2394-2789/© 2022 Innovative Publication, All rights reserved. 28