A New Validated Stability Indicating RP-HPLC Method for Simultaneous Estimation of Pyridoxine Hydrochloride and Meclizine Hydrochloride in Pharmaceutical Solid Dosage Forms
A simple, specific, accurate, precise stability indicating reversed-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous determination of pyridoxine hydrochloride (PYH) and meclizine hydrochloride (MEH). An isocratic separation of PYH and MEH were achieved on C 18, 250 × 4.6？mm ID, 5？μm particle size columns at column oven temperature 37°C with a flow rate of 0.5？mL？min？1 and using a diode array detector to monitor the detection at 254？nm. The mobile phase consisted of buffer？:？acetonitrile？:？trifluoroacetic acid at a ratio of 30？:？70？:？0.1？(v/v). The retention times of PYH and MEH was found to be 5.25 and 10.14？min, respectively. Suitability, specificity, linearity, accuracy, precision, stability, and sensitivity of this method for the quantitative determination of the drugs were proved by validation in accordance with the requirements laid down by International Conference on Harmonization (ICH) Q2 (R1) guidelines. The proposed method is reliable and robust and can be used as quality control tool for the estimation of these drugs in combined pharmaceutical solid dosage forms. 1. Introduction Pyridoxine hydrochloride (PYH) is chemically 3, 4-pyridinediacetonitrile, 5-hydroxy-6-methyl, hydrochloride (Figure 1). It is a water-soluble vitamin and involved principally in amino acid, carbohydrate, and fat metabolism [1]. It is also required for the formation of hemoglobin [2]. Meclizine hydrochloride (MEH) (Figure 2) is often used as “meclozine” which is chemically 1-[(4-Chlorophenyl)(phenyl)methyl]-4-(3-methylbenzyl)piperazine, dihydrochloride monohydrate, a first-generation antihistamine of the piperazine class. Meclizine is effective in inhibiting the symptoms of motion sickness, such as nausea, vomiting, and dizziness. PYH is official in IP [3], BP [4, 5], and USP [6], and MEH is also official in BP [4, 5] and USP [6]. The pharmacopeias describe potentiometric, spectrophotometrics and HPLC method for the determination of PYH and MEH individually from the bulk and tablet dosage form. No reversed-phase high-performance liquid chromatography (RP-HPLC) method is reported in pharmacopeias for the simultaneous estimation of PYH and MEH from their combined formulation, though there are various methods for the determination of PYH and MEH by spectrophotometric [7–12], voltammetric [13], HPLC [14–16], electrophoresis [17], GLC [18], HPTLC [19], and TLC [20] methods in different pharmaceutical dosages forms. The present work describes the development and validation of stability indicating RP-HPLC method,
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