RP-HPLC Method Development and Validation for...

RP-HPLC Method Development and Validation for Estimation of Dolutegravir Sodium in Bulk Drug and Tablet Dosage Form

Author Name : Manoj Barhate, Dr. Sanjay Bhawar, Rajashri Ghogare

ABSTRACT Several spectrophotometric and HPLC methods have been reported for determination of Dolutegravir sodium in bulk drugs and in pharmaceutical dosage forms. Hence, in the present study, a new, sensitive, reproducible, suitable and robust reversed-phase high performance liquid chromatography method was developed and validated for the determination of Dolutegravir sodium in bulk drug and in tablet formulation. In RP-HPLC method, Acetonitrile and 0.1 % OPA (70:30 % v/v) was used as mobile phase, at a flow rate of 1.0 ml/min, on HPLC system containing UV- detector with Open lab EZ chrome software and Column Kromasil C18 having dimensions 250 mm X 4.6 mm, 5 µm. The detection was carried out at 258 nm. The method gave suitable retention time that is 3.03 min for Dolutegravir . The results of analysis in the method were validated in terms of Filter study, Solution stability, specificity, Linearity, accuracy, precision (Repeatability and intermediate precision), limit of detection, limit of quantification and robustness. A simple and precise method was developed for the assay of Dolutegravir sodium in bulk drug and in tablet formulation. The method need regular reagents for doing analysis and also less time consuming, it can be performed routinely in industry for routine analysis of bulk drug and marketed product of Dolutegravir.