DEVELOPMENT AND VALIDATION OF UV-SPECTROSCOPIC FIRST DERIVATIVE AND HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHY ANALYTICAL METHODS FOR SIMULTANEOUS ESTIMATION OF DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE AND SAXAGLIPTIN HYDROCHLORIDE IN SYNTHETIC MIXTURE
Shveta H. Parmar*, Dr. Shailesh V. Luhar, Dr. Sachin B. Narkhede
ABSTRACT
In the present study two analytical Methods were developed for the estimation of Dapagliflozin propanediol and saxagliptin Hydrochloride in Synthetic Method. where as in method A ,first derivative method based on measurement of absorbance at two wavelengths 225 nm and 217 nm using UV visible spectrophotometer with 1cm matched quartz cells and methanol solvent were employed in this method. The Developed method obeyed Beer’s-Lambert’s law in the concentration range of 20-100μg/ml, having correlation coefficient for Dapagliflozin was 0.984 and 10-50 μg/ml, having correlation coefficient for Metformin hydrochloride was 0.982. In method B, High performance thin Layer Chromatography using silica gel aluminium plate 60F254(10*10cm)as stationary Phase and Chloroform: Ethyl acetate: methanol: ammonia (6:2:2:2 Drops) as Mobile Phase .the developed plates scanned densiometrically using UV 210nm wavelength. The Rf value of DAPA and SAXA was found to be 0.30 and 0.54 respectively. Both the method validated for different validation parameter such as linearity, accuracy, precision, LOD, LOQ and robustness and the result were found to be within the acceptance limit as per the guideline of international conference on Harmonization (ICH).
Keywords: Dapagliflozin propanediol, Saxagliptin Hydrochloride, first derivative method, HPTLC method, Validation, ICH.
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