Abstract

Development and Validation of Forced Degradation Studies of Lopinavir Using RP-HPLC and Characterization of Degradants by LC-MS/MS

Author(s): Khagga Bhavyasri, V. Murali Balaram R. Nageswarao, D. Rambabu and M. Ajitha

Aim of the present work was to develop simple, shorter and effective HPLC method with UV detection (240 nm) and subsequent validation for forced degradation studies of lopinavir using RP-HPLC and characterization of degradants by LC-MS/MS. The method uses isocratic the mobile phase mixture of buffer and acetonitrile taken in the ratio in the ratio of 45:55 (v/v) on Hypersil BDS, C18, 100 x 4.6 mm, 5 μm column. The RSD for five injections was observed to 1.1 percentage and linearity range of 25-150 percentage of label claim established with 0.999 correlation. The observed result shows that the method was rapid, precise, accurate and simple. The method was validated as per ICH guidelines.