Development and Validation of a RP-HPLC Method for the Simultaneous Estimation of Prochlorperazine Maleate and Pyridoxine Hydrochloride in Combined Dosage Forms

Abstract

A simple, precise and economical RP-HPLC method was developed and validated for simultaneous determination of prochlorperazine maleate and pyridoxine hydrochloride in pharmaceutical dosage form. The method involves the use of easily available inexpensive laboratory reagents. The separation was achieved on C18 (250 mm× 4.6mm) 5μm column with isocratic flow. The mobile phase at flow rate of 1.2 ml/min, consisted of acetonitrile-water (60: 40 V/V), pH adjusted to 3.0 with triethylamine. The UV detection was carried out at 267.5 nm. A linear response was observed over the concentration range of 1–5μg/ml of prochlorperazine maleate and the concentration range of 5–25μg/ml of pyridoxine hydrochloride. The method was successfully validated in accordance to ICH guidelines acceptance criteria for specificity, linearity, accuracy, precision, ruggedness and system suitability. The results of recovery study were found to be within the prescribed limit of 98–102%. During the linearity study, it was observed that absorbance values of prochlorperazine maleate and pyridoxine hydrochloride in marketed formulation were linear and r2 close to 1 for this method of analysis. The degree of reproducibility of the results obtained as a result of small deliberate variations in the method parameters and by changing analytical operators has proven that the method is robust and rugged.