HPLC Method Development and Validation for Residue Analysis of Steroid

Abstract

A High-Performance Liquid Chromatography technique was developed for Residue Analysis of Megestrol Acetate collected from pharmaceutical manufacturing equipment’s. The samples were collected by Texwipe swab, separated by using Primesil C18 150mm x 4.6 mm, 5µm (Part No.: PC181504650) stationary phase and 65:35 of Acetonitrile: water as mobile phase in isocratic mode of elution. The residues were extracted from the swab in ultrasonic bath and later determined at a wavelength of 280nm. The detection was done using PDA detector for improved sensitivity. The developed method was then validated depending on the parameters of Cleaning Validation suggested by FDA. The method was found to be linear in a concentration range of 0.03-15 μg/ml. RSD of six replicates (Precision) were found to be 1% and the Recovery was found to be >90%. This method can be used to determine trace residues by Megestrol Acetate API on the manufacturing equipment’s in order to avoid any cross contamination during batch manufacturing.