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ABSTRACT:
A simple, accurate, economical and reproducible procedure for simultaneous estimation of Prochlorperazine Maleate and Pyridoxine Hydrochloride in their tablet dosage form is described. In this method 0.3M HCl was utilized as solvent. In first order derivative spectroscopic method, two wavelengths 252nm for prochlorperazine maleate (zero cross for pyridoxine hydrochloride) and 228.5nm for pyridoxine hydrochloride (zero cross for prochlorperazine maleate) were selected. Both drugs obey Beer-Lambert's law in concentration range of 1-5 µg/ml (prochlorperazine maleate) and 5-25 µg/ml (pyridoxine hydrochloride) respectively in 0.3M HCl. The suggested method is validated by using ICH validation parameters like accuracy, precision, specificity, ruggdness and linearity. 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 in the range of 80% to 120% of test concentration with R2 close to 1 for this method of analysis.
KEYWORDS: Prochlorperazine Maleate, Pyridoxine Hydrochloride, first order derivative spectroscopic method
INTRODUCTION:
Prochlorperazine maleate (PCM), 2-Chloro-10-[3-(4-methylpiperazin-1- yl)propyl] 10 H phenothiazine bis[hydrogen(Z)-butenedioate] (fig. 1), is an antiemetic and antipsychotic drug [1] while pyridoxine hydrochloride (PDH), 5-Hydroxy-6-methyl-3,4-pyridine dimethanol hydrochloride (fig. 2), is a nutritional component [2]. Both the drugs are official in IP, BP and USP. Literature survey revealed that HPLC [3, 4] methods have been reported for pyridoxine hydrochloride with other drugs. However, no method is reported for simultaneous estimation of these two drugs in combined dosage form. This prompted us to develop simple, rapid, accurate, economical and sensitive simultaneous estimation method for their determination in combination.
MATERIAL AND METHODS:
Instrumentation:
UV-Visible double beam spectrophotometer, model 1700 Pharmaspec with 1 cm quartz cells was used. Electronic balance (Modal AUW-220D) was used for weighing.
Reagents and chemicals:
The chemicals used were of analytical grade. Commercially available tablets of prochlorperazine maleate and pyridoxine hydrochloride in combination were procured from local market. Standard prochlorperazine maleate and pyridoxine hydrochloride were received as giftsample from FDA Mumbai.
Selection of solvent:
A 0.3M HCl solution was selected as the suitable solvent for the estimation of PCM and PDH.
Preparation of standard stock solution:
Standard stock solutions of PCM and PDH were prepared separately by dissolving 25 mg each of standard PCM and PDH in 0.3M...