RP-HPLC Method Development and Validation for Simultaneous Estimation of Paracetamol and Prochlorperazine Maleate

Abstract

A simple, precise, accurate, robust, and stability-indicating reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous estimation of Paracetamol (PCM) and Prochlorperazine Maleate (PCZM) in pharmaceutical dosage forms. Chromatographic separation was achieved on a Cosmosil C18 column (250 mm× 4.6 mm, 5 μm) using Methanol:Water (60:40, v/v) adjusted to pH 3.0 with orthophosphoric acid as the optimized mobile phase. The mobile phase was delivered at a flow rate of 0.9 mL/min, and detection was carried out at 251 nm. Under the optimized chromatographic conditions, Paracetamol and Prochlorperazine Maleate were eluted at retention times of 4.5 min and 7.0 min, respectively. The method was validated in accordance with ICH Q2(R1) guidelines for linearity, accuracy, precision, robustness, sensitivity, and specificity. Excellent linearity was obtained over the concentration range of 10–50 μg/mL with correlation coefficients (R²) of 0.9998 for PCM and 0.9995 for PCZM. Accuracy studies performed at 50%, 100%, and 150% concentration levels yielded mean recoveries of 100.15%, 99.84%, and 100.08% for PCM, while recoveries of 100.70%, 99.49%, and 100.13% were obtained for PCZM. Precision studies demonstrated excellent repeatability with %RSD values of 0.08% for PCM and 0.31% for PCZM.Furthermore, forced degradation studies under acidic, alkaline, oxidative, thermal, and photolytic stress conditions confirmed the stability-indicating capability of the developed method. The proposed RPHPLC method was found to be reliable, sensitive, accurate, and suitable for routine quality control analysis and stability assessment of Paracetamol and Prochlorperazine Maleate in pharmaceutical formulations.