Separation and Determination of Prochlorperazine Maleate and Pyridoxine Hydrochloride in Tablet Formulation by RP-HPLC

A reverse phase HPLC method is developed for the simultaneous analysis of Prochlorperazine Maleate (PCM) and Pyridoxine hydrochloride (PDH) in pharmaceutical preparations. HPLC was carried out on a C18 column using methanol: water (40:60 v/v, pH 7) as a mobile phase at 1 mL/min flow rate and the effluent was monitored at 272 nm. The retention time for PCM was found to be 6.28 min and for PDH was found to be 3.48 min. The linearity was obtained in the concentration range of 5-25 μg/ml respectively for PCM and PDH. The method was successfully applied in the analysis of tablet dosage form because no chromatographic interferences from formulation recipients were found. In this study, a HPLC method was successfully applied for the quantitative assay of PCM and PDH in tablets which is simple, rapid, no interferences from formulation recipients and does not require any separation step for each drug. The method was validated as per the ICH guidelines. This method is precise, accurate and easy to analysis PCM and PDH in tablets.