Development and Validation of RP-HPLC Method for the Determination of Ropinirole Hydrochloride in Bulk and Pharmaceutical Dosage Forms

Abstract

A simple, precise, rapid and accurate RP-HPLC method was developed for the estimation of Ropinirole hydrochloride in pure and pharmaceutical dosage forms. The method employed a Phenomenex C8 column (250 × 4.6mm, 5µm) and a mobile phase consisting of 0.1% orthophosphoric acid (pH 2.61) and methanol in the ratio of 50:50 v/v. The flow rate was optimized at 1.2mL/min and the effluents were monitored at 248 nm over a run time of 10.0 min. where the analyte showed the retention at 2.91±0.26 min. The detector response was linear in the concentration of 1-100µg/mL (y = 40236x – 10950). The limit of detection and limit of quantification were found to be 0.0007µg/mL and 0.0021µg/mL respectively. The method was validated as per ICH guidelines and was found to be sensitive, accurate, precise and robust while satisfying all the system suitability. The method was also tested for its stability indicating capability by performing the forced degradation studies and the drug was almost stable in all the exposed conditions with very minor degradations observed. The developed method was used for the assay of the drug in marketed tablets and the percentage assay was found to be 99.32±0.83 %w/w. The results of the study depict that the proposed RP-HPLC method is specific and sensitive for the routine analysis of Ropinirole hydrochloride in bulk drug and in its pharmaceutical dosage form.