STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF DAPAGLIFLOZIN IN BULK AND TABLET DOSAGE FORM BY UV SPECTROPHOTOMETRY

Abstract

Dapagliflozin is an anti-diabetic drug that works on the kidneys of reabsorption of glucose in kidneys by the sodium-glucose co-transporter2 (SGLT2). It is used in patients with type 2 diabetes. It is administered as tablets. The objective of the present work is to develop a novel simple and economic method for the quantification of dapagliflozin in bulk drug and in tablet formulation. Further this study is designed to validate the developed methods as per ICH guidelines. The quantification process was performed on UV-spectrophotometer. Different analytical performance parameters such as linearity, precision, accuracy, limit of detection (LOD), limit of quantification (LOQ) repeatability, stability studies were determined according to ICH guidelines. The solutions of standard and sample were prepared in methanol after suitable dilutions. 100µg/ml of the Dapagliflozin was prepared and scanned in the UV visible range 400 to 200nm. In the quantitative determination of the drug was carried at selected wavelength 224nm and the linearity range was formed to be 1 to 10µg/ml and r2 (0.9995). LOD and LOQ for dapagliflozin was found to be 0.0262µg/ml and 0.079µg/ml. The proposed method can be adopted for routine quality control for estimation of drug in formulation. Key words: Dapagliflozin, spectrophotometric method, validation, linearity, precision