RP-HPLC method development and validation for evaluation of drug | 5372
Journal of Developing Drugs

Journal of Developing Drugs
Open Access

ISSN: 2329-6631

RP-HPLC method development and validation for evaluation of drug residue after cleaning of equipments of ointment formulation

4th International Summit on GMP, GCP & Quality Control

October 26-28, 2015 Hyderabad, India

Monika S Sonawane

Savitribai Phule Pune University, India

Posters-Accepted Abstracts: J Develop Drugs

Abstract :

Manufacturing of Pharmaceutical drug products and drug substances shall demonstrate a control to reproduce consistently the desired quality of product, wherein the control of cross-contamination plays an important role. Residual materials from the previous batch of the same product or from different product may be carried to the next batch of the product, which in-turn may alter the impurity profile of the subjected product. An effective cleaning shall be in place to provide documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product. for the same purpose after cleaning of manufacturing equipments of ointment formulation swab sampling was done and A novel RP-HPLC method was developed and validated as per ICH guidelines for the quantitative estimation of critical drug Clioquinol found in swab sample of Ointmen formulation. A reverse phase HPLC-method was developed using Spherisorb Phenyl , 250x4.6 mm, 5 �?¼m column and a mobile phase were and acetonitrile:methanol: Water (30:20:50 v/v) with Nickel Chloride(0.024%). The detector set at 273 nm with flow rate of 1 mL.min-1. The method is linear having limit of detection (LOD) is 0.125 �?¼g/mL 0.and limit of quantification (LOQ) is 5 �?¼g/mL. Specificity,Recovery,System Suitability, Precision, Stability Crieterieas were validated as per ICH guidelines.

Biography :

Monika S. Sonawane has completed her M.Pharm in 2013 From Savitribai Phule, Pune University and presently working as PhD Scholar in same University.and postdoctoral studies from Stanford University School of Medicine.