Development and Validation of RP-HPLC Method for the Assay of Prochlorperazine Maleate in Tablet Dosage Form

In the presented research work a simple, specific, accurate and isocratic RP-HPLC (Reverse Phase High Performance Lliquid Chromatographic) method was developed and validated for the assay of Prochlorperazine Maleate in tablet dosage forms. The method makes use of affordable laboratory reagents that are readily available. The mixture of buffer pH 4.0:ACN (50:50 v/v) was used as a mobile phase with isocratic elution at a flow rate of 1.5 ml/min. A Inertsil ODS-3 column (250 x 4.6mm, 5µm) was used for chromatographic separation. The effluent was detected by using UV detector at a wavelength of 254nm and the run time was 8 minutes. The retention time was found to be 4.1 minute for Prochlorperazine Maleate. The method showed linearity over the range of 50-150μg/ml with correlation coefficient r² = 0.9999. The % RSD for intraday and interday precision was 0.38 and 0.25 respectively. The system suitability parameters for Prochlorperazine Maleate, such as theoretical plates and tailing factor, were found to be 8430 and 1.25 respectively. The % recoveries were in the range of 98 to 102 (RSD < 2%).There was no interference observed in the blank injections at the RT of Prochlorperazine Maleate, Hence the method proved to be specific. The drug shows stability in solution upto 32 hrs. The propsed method was validated for the parameters such as accuracy, linearity, specificity, solution stability etc. as per ICH gudelines. Overall, a new RP-HPLC method was developed and successfully validated for the assay of Prochlorperazine Maleate in tablet dosage form.