Pharmaceutical Technology Division, Department of Chemical Technology, Dr. Babasaheb Ambedkar Marathwada University, Aurangabad-431001, Maharashtra, India
A new, simple, rapid, accurate and precise high-performance thin layer chromatography (HPLC) method has been developed and validated according to the guidelines of the International Conference on Harmonization (ICH Q2(R1) for the estimation of dapagliflozin in bulk and formulation. The chromatographic analysis was performed by an Agilent HPLC instrument using a BDS Hypersil, C-18, 250mmx4.6mm, 5 ?m and mobile phase comprising 0.1% ortho-phosphoric acid in water and acetonitrile (65:35 v/v) at flow rate of 1.0 ml/min. The eluent was monitored at 225 nm for determination of dapagliflozin. The total run time was 10 min and the average retention time of Dapagliflozin was found to be 5.31 min. The calibration curves were linear over the range of 1-20 ng/mL (R2 = 0.999). The intra- and inter-day accuracy and precision values for all the analytes were within the acceptable range. The LOD and LOQ were 0.2076 and 0.9628 ng/mL. The developed method was found to be robust. A simple, precise, accurate, linear and rapid RP-HPLC method was developed and validated as per ICH guidelines. The results suggest that the developed method was found to be robust and it can be applicable in routine analysis and efficiently used for the estimation of dapagliflozin in bulk as well as combined dosage form.
Sachin Bhusari*, Pritesh Jawale, Pravin Wakte, Development and Validation of Reverse-Phase High-Performance Liquid Chromatography Method for Estimation of Dapagliflozin in Bulk and Formulation, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 10, 78-84. https://doi.org/10.5281/zenodo.8428473