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Stability - Indicating RP - HPLC Method for Estimation of Erdosteine and its Degradation Products in Pharmaceutical Dosage Form

Author(s): Anita P. Ayre | Harsha l A. Pawar

Journal: Journal of Pharmaceutical and Bioanalytical Science
ISSN 2278-828X

Volume: 1;
Issue: 1;
Start page: 2;
Date: 2012;
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Keywords: Erdosteine | Validation | Degradation product | Mucolytic | RP - HPLC

A simple, selective, precise and accurate stability-indicating high-performance liquid chromatographic method for analysis of Erdosteine and its degradation products in tablet dosage form was developed and validated. The stability indicating ability of the method was determined by performing forced degradation studies which indicated susceptibility of the drug under acidic and neutral hydrolytic conditions. Separation of drug from its degradation products was achieved by isocratic elution using a mobile phase consisting of Acetonitrile : 0.01M Phosphate buffer,pH 5.8 (80:20 v/v)through a HiQSil C18column (250 X 4.6mm, 5 μm) at a flow rate of 1ml min-1with UV-detection(270nm) at ambient temperature. Validation of the developed HPLC method was performed using an external standard. The method was found to be linear over a range of 5-50μg ml-1and demonstrated to be precise, accurate,specific and robust. The results obtained verify that the method can be used for its intended purpose.
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