DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD AND RP – HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF DAPAGLIFLOZIN PROPANEDIOL AND GLIMEPIRIDE IN SYNTHETIC MIXTURE
*Ashish Patel and Dr. Dilip maheshwari
An accurate, precise and reproducible UV-spectrophotometric methods and liquid chromatographic assay method were developed and validated for the determination of Dapagliflozin propanediol and Glimepiride in synthetic mixture. Spectrophotometric estimation was done by derivative spectroscopic method and methanol as solvent. In this method λmax for Dapagliflozin propanediol and Glimepiride were selected at 288 nm and 224nm. RP-HPLC analysis was carried out using Pearless C-18 column (4.6 x 250mm, 5μ particle size) and mobile phase composed of Acetonitrile : 10% Ortho-phosphoric acid in water pH 6.0 (70:30% v/v)at a flow rate of 1.0 ml/min and chromatogram was recorded at 228 nm. Linearity was evaluated over the concentration range of 5 -30 μg/ml and 5-30 μg/ml for Dapagliflozin propanediol and Glimepiride in UV spectrophotometric and in RP-HPLC method Linearity was evaluated over the concentration range of 1 -5 μg/ml and 1-5 μg/ml for Dapagliflozin propanediol and Glimepiride (the value of r2 = 0.9978 and r2= 0.995 found were by UV method for DAPA and GLM and the value of r2 = 0.997 and r2= 0.996 found were by RP-HPLC method for DAPA and GLM). The developed methods were validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values therefore the both methods can be used for routine monitoring of DAPA and GLM in the assay of Synthetic mixture of both drugs.
Keywords: Dapagliflozin propanediol and Glimepiride in synthetic mixture.
[Full Text Article]