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Reverse Phase High Performance Liquid Chromatography for Method Development Validation of Omeprazole in Bulk and Pharmaceutical Dosage Form Rele Rajan V.*, Tiwatane Prathamesh P. Central Research Laboratory, D.G. Ruparel College, Matunga, Mumbai, 400 016 *Corresponding Author E-mail: drvinraj@gmail.com
Online published on 2 June, 2018. Abstract The validation of omeprazole from combined dosage form i.e. tablets was described by high performance liquid chromatography method with separation of drugs on BDS Hypersil C18 (150 x 4.6 mm i.d.) and 5 μ particle size. A mixture of buffer and acetonitrile (65: 35% (v/v)) was constituted as mobile phase. The chromatograms were studied at 230 nm as wavelength. The mobile phase was also used as a diluent. A validated of method was studied for linear regression, accuracy, method as well as system precision. The robustness study was done for change in wavelength, mobile phase composition and flow rate as per ICH guidelines. The method has been successfully used to analyze omeprazole from dosage form i.e. tablets and drotaverine from combined dosage form i.e. tablets. Top Keywords Omeprazole, tri-ethyl amine, ortho phosphoric acid acetonitile. Top | |
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