DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD IN MULTI-COMPONENT FORMULATION
Keywords:
Reverse Phase High Performance Liquid Chromatography, Multi-Component formulations, Analytical Method Development and Validation.Abstract
The aim of the present work was focused on development of an analytical method for simultaneous estimation of drugs in multi-component dosage form by using RP-HPLC. Chromatographic separation techniques are one of the most widely used techniques for analysis of a multi-component formulation. HPLC technique allows for the separation as well as analysis of different drugs that are present in a combined formulation. The technique also allows for separation of the respective drugs from the excipients contained in the formulation and thus each drug in a multi-component formulation can be easily separated and hence analyzed. Analytical method was developed in order to carry out the assay of the respective drugs present in the tablet formulation. Validation studies were performed in order to assess the validation parameters for the analytical method developed in accordance to ICH Guidelines.
