Abstract

DEVELOPMENT AND VALIDATION OF ANALYTICAL RP-HPLC METHOD FOR ESTIMATION OF CARBIDOPA AND LEVODOPA IN BULK AND THEIR COMBINATION USING QUALITY BY DESIGN APPROACH

Husna Kanwal Qureshi and Kaunain Fatima*

ABSTRACT

Aim of present work was to develop a simple, rapid and cost effective method for estimation of Carbidopa and Levodopa in bulk and Marketed Formulations by RP HPLC and Stability Indicating method by applying Quality By Design Approach., so that it can be applied for the routine analysis of drug in Quality Control laboratories and also estimation of degradation behavior of drug By RP-HPLC. For HPLC Method Development Agilent make of HPLC is used using Acetonitrile and (KH2PO4) Phosphate Buffer with pH 2.8 in the ratio of 60:40% v/v. For application of QBD Approach, Design Expert®13 software was used. After Method Development, Validation has been performed as per ICH guidelines. In Linearity correlation coefficients for Carbidopa and Levodopa was found to be less than 0.9996 and 0.9997 respectively. For Precision % RSD were found to be less than 1.77 and 0.595%, which indicate that the developed method to be precise. For Accuracy, % Recovery was found to be in between 98 % -102%, which indicating method to be Accurate. For RP-HPLC, various system suitability parameters were found to be specific as per ICH guideline i.e. tailing, theoretical plates, Resolution. QBD Approach was applied during Method Development by RP-HPLC which gives the advantage to the method to be sensitive and Cost effective.

Keywords: Carbidopa and Levodopa, ICH Guidelines, Method Development, QbD.