Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATIION OF DEXTROMETHORPHAN SUSPENSION

Richa Patel*, Komal Patel and Ankit Chaudhary

ABSTRACT

One simple, specific, accurate, precise and reproducible method have been developed and validated for the Simultaneous Estimation of Dextromethorphan in suspension. In Reverse Phase High Performance Liquid Chromatography Method the chromatographic system was equipped with Eclipse- XDB C18 (150 X 4.6 mm, 5μm) Agilent as stationary phase and UV detector set at 225 nm, in conjunction with a mobile phase of 0.05M Potassium Dihydrogen Phosphate buffer (pH- 3.0) and Acetonitrile in the ratio of 80:20% v/v (pH 3.0, adjusted with 1% Orthophosphoric acid) at a flow rate of 1.0 ml/min. The described method was linear over a concentration range of 50-150 μg/ml for Dextromethorphan. The retention time of Dextromethorphan was 3.080 min. The % recoveries of the both the drugs were found to be 100.94-101.91% for Dextromethorphan. Method were statistically validated for accuracy, precision, specificity, LOD, LOQ and robustness according to ICH guidelines and can be used for analysis of combined Tablet. In UV spectrophotometric method was a determination using the First Order Derivative Method at 225 nm over the concentration range 0.5-15 μg/ml for Dextromethorphan. Method were statistically validated for accuracy, precision, LOD and LOQ according to ICH guidelines and can be used for analysis of suspension. The propose method enables rapid quantification and simultaneous analysis of drug from syrup without any interference of excipients. So, the method can be used for routine analysis.

Keywords: Dextromthorphan, RP-HPLC Method, Force Degradation, Method Validation.