STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF DAPAGLIFLOZIN AND SITAGLIPTIN IN MARKETED FORMULATION
Pradumn Kumar*, Mrs. Swarupa Ashok Wankhade, Mr. Muraree Lal, Dr. Avinash
Krishnrao Kondalkar
ABSTRACT
This research aims to develop a stability-indicating analytical method for the accurate estimation of Dapagliflozin and Sitagliptin in marketed pharmaceutical formulations. Dapagliflozin and Sitagliptin are commonly used drugs for the management of Type 2 diabetes. The developed method involves high-performance liquid chromatography (HPLC) as the primary analytical technique, coupled with a suitable detector. Various chromatographic conditions, such as column selection, mobile phase composition, and detection wavelength, were optimized to separate and quantify Dapagliflozin and Sitagliptin efficiently. Validation parameters, including linearity, precision, accuracy, limit of detection (LOD), limit of quantification (LOQ), and robustness, were assessed according to International Conference on Harmonisation (ICH) guidelines. The method exhibited a wide linear range, good precision, and accuracy, meeting the requirements for routine pharmaceutical analysis. The developed stability-indicating method was successfully applied to the analysis of marketed formulations containing Dapagliflozin and Sitagliptin. The results demonstrated the method's reliability for quantifying the active ingredients in these formulations. In conclusion, the presented stability-indicating HPLC method offers a reliable and efficient means of analyzing Dapagliflozin and Sitagliptin in marketed formulations. This method can be employed for routine quality control analysis, ensuring the stability and potency of these essential drugs for diabetic patients.
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