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- Title
A New Validated Stability Indicating RP-HPLC Method for Simultaneous Estimation of Pyridoxine Hydrochloride and Meclizine Hydrochloride in Pharmaceutical Solid Dosage Forms.
- Authors
Nawaz, Md. Saddam
- Abstract
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 × 4.6mm ID, 5 µm particle size columns at column oven temperature 37°Cwith a flowrate of 0.5mLmin-1 and using a diode array detector tomonitor 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 InternationalConference onHarmonization (ICH) Q2 (R1) guidelines. Theproposed 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.
- Subjects
HIGH performance liquid chromatography; MECLIZINE (Drug); VITAMIN B6; SOLID dosage forms; PHARMACEUTICAL chemistry; INTERNATIONAL Conference on Harmonisation; GUIDELINES
- Publication
Chromatography Research International, 2013, p1
- ISSN
2090-3502
- Publication type
Article
- DOI
10.1155/2013/747060