Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS DETERMINATION OF VILDAGLIPTIN HYDROCHLORIDE AND DAPAGLIFLOZIN BENZOATE BY RPHPLC METHOD IN TABLET DOSAGE FORM

Vijayamirtharaj Ramaswamy*, Deepika Raja, Kalai Selvi Ponnusamy, Chithra Manickam, Senthil Kumar Natesan

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Abstract

The objective of this study was to develop a new simple, rapid, sensitive, and validated reversed phase-high performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Vildagliptin Hydrochloride and Dapagliflozin Benzoate in tablet dosage form. By utilizing RP-HPLC, this method fills a gap in the existing literature. Optimizing various parameters of the chromatographic process was key to developing an effective method for separating and detecting drugs. International guidelines and regulatory requirements were followed for the validation of the method, including specificity, linearity, accuracy, Precision, robustness, and suitability for the system. For analysis of mixed solutions containing Vildagliptin Hydrochloride and Dapagliflozin benzoate, a Chromatographic separation was achieved on a Phenomenex C 18 column (150x4.6mm), 5μm, a mobile phase ratio consisting of Buffer: ACN: Methanol (30:5:65) at flow rate 1.2 ml/min, and total run time 8 min, The injection volume 20μl. The detection wavelength is 249nm. Approximately 2000 plates were found, indicating a successful chromatographic separation. With a tailing factor of less than 2 and a well-resolved peak, the peaks appear symmetrical and well-resolved. In order to ensure there were no interfering peaks, retention times for Vildagliptin Hydrochloride and Dapagliflozin benzoate were found to be 2.078 and 3.238 min. As for Vildagliptin Hydrochloride, the correlation coefficient (R²) is 0.9993 and Dapagliflozin benzoate is 0.9996. This indicates a good linear relationship between drug concentrations and peak areas based on the high correlation coefficients. For Vildagliptin Hydrochloride and Dapagliflozin benzoate, the %RSD values were 0.09% and 1.42%, respectively, below the acceptable limit of 2%. As a result, the method is accurate and repeatable. In the study of Vildagliptin Hydrochloride, the mean percent recovery was 100.09%, while in the study of Dapagliflozin benzoate, the mean percent recovery 100.34%. Under varied conditions, both Vildagliptin Hydrochloride and Dapagliflozin benzoate showed %RSD values within the Acceptable range of 2%, demonstrating the robustness and reliability of the method. This Study concluded that valuable insight is provided into the use of validated RP-HPLC methods in this study, which contributes significantly to the evolution of pharmaceutical analytical techniques.

Keywords: Vildagliptin Hydrochloride and Dapagliflozin benzoate, RP-HPLC, Method development, Method validation.