A VALIDATED RP-HPLC METHOD FOR THE DETERMINATION OF PROPAFENONE HCL IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORM
*Muggu Murali Krishna, M. Lakshmi Surekha, R. Padma and Ch. Ajay.
ABSTRACT
A simple, rapid, accurate, precise, robust and reproducible reverse phase high performance liquid chromatographic method was developed for the determination of Propafenone HCl in pure drug and pharmaceutical dosage form. The quantification was carried out using enable Inertsil ODS-3Vs column in a binary mode with mobile phase comprising of Acetonitrile: Methanol: Water (80:20) in the ratio of 80:20 %v/v at flow rate 1.2mLl/min, detection was carried out at 235 nm using PDA detector with injection volume 20μl, the retention time was found to be 3.33min. The proposed method was validated as per ICH guidelines. The method produced linear response in the concentration range of 10-50μg/ml (R2 0.9997). The recovery studies were carried out and found to be within 100%. %RSD was found to be 2%. LOD and LOQ of propfenone HCl for the method were found to be 4.74μg/ml and 12.04μg/ml respectively. The proposed method was statistically evaluated and can be applied for the routine analysis, quality control of raw materials, formulation of different strengths, dissolution studies and bioequivalence studies for the same formulation of propafenone HCl.
Keywords: Propafenone HCl and RP-HPLC: PDA Detetion; ICH Validation.
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