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

Research Article

Austin J Anal Pharm Chem. 2014;1(3): 1012.

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

Khanage SG*, Mohite PB, Dudhade MR and Deshmukh VK

Department of Pharmaceutical chemistry and PG studies, MES College of Pharmacy, India

*Corresponding author: :Khanage SG, MES College of Pharmacy, Sonai, At post-Sonai, Tq- Newasa, Ahmednagar, Maharashtra, India.

Received: August 01, 2014; Accepted: August 20, 2014; Published: August 23, 2014

Abstract

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.

Keywords: HPLC; Accuracy; Precision; ICH guidelines

Introduction

Prochlorperazine Maleate (PCM) is a well known phenothiazine analog, chemically it is [2-chloro-10-(3, 4’-methylpiperazin-1-yl) pylpropyl) phenothiazine; Maleate]. PCM (Figure 1) is widely used for the treatment of nausea, vomiting, migraine, anxiety and sometimes schizophrenia [1]. Pyridoxine hydrochloride (PDH) is chemically, 5-hydroxy-6-methyl-3, 4-pyridinedimethanol hydrochloride [2] (Figure 2). The term B-group vitamins usually refers to Thiamine, Riboflavin, Pyridoxine, Nicotinic acid, Pantothenic acid, Biotin, Cyanocobalamine and Folic acid. Vitamins are reported to reduce the damage by free radicals and prevent degenerative disease [3]. Pyridoxine hydrochloride is known as vitamin B6 and extensively used as nutritional component. Vitamins B6 and B2 are involved in the metabolism of homocysteine, vitamin B6 serves as a cofactor for cystathionine ß-synthase and cystathioninelyase, which convert homocysteine to cystathionine and then to cysteine. Vitamin B6 exists in seven forms: pyridoxine (PN), pyridoxine 5’-phosphate (PNP), pyridoxal (PL), pyridoxal 5’-phosphate (PLP), pyridoxamine (PM), pyridoxamine 5’-phosphate (PMP), and the catabolite, 4-pyridoxic acid. The Pyridoxine form is a water-soluble vitamin. It was discovered in 1934 by P. Gyorgy [4]. The management of vomiting has been always a problem for a physician and the search for a safe and effective alternative is still on. The combination of the PCM (5 mg) and PDH (25 mg) is used for getting relief from vomiting and nausea symptoms and used as an anti-emetic.