Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF NELFINAVIR IN PURE FORM AND PHARMACEUTICAL DOSAGE FORM

Namratha Sunkara*, K. Sai Bhavani, S. Rehana, D. Sreeja and Farheen Begum

Abstract

RP-HPLC method was developed for Nelfinavir in bulk and pharmaceutical dosage form with a maximum absorbance found to be at 240nm and peak purity was excellent. The method was developed by using mobile phase ACN: Methanol (60:40% v/v) at a flow rate of 1ml/min using Symmetry ODS C18 (4.6 x 150mm, 5m)column. The following method has been validated as per the ICH guidelines. The method has been validated for Accuracy, Precision, Linearity, System suitability, Specificity, Robustness. The method showed linearity in a range of 10, 20, 30, 40 and 50 μg / ml. The accuracy for 50%, 100% and 125% was found to be 100.42%. the retention time is found to be 3.155 min. It is found that the method of RP-HPLC with UV-detection system for the analysis of Nelfinavir is straight forward and applied in qualitative and quantitative analysis. This method is simple, rapid, selective and inexpensive. The proposed method for estimation of selected drug Nelfinavir was successfully applied in pharmaceutical formulation.

Keywords: RP-HPLC method was developed for Nelfinavir formulation.