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ABSTRACT:
A validation method of omeprazole and drotaverine hydrochloride from combined dosage form i.e. tablets was described by reverse phase high performance liquid chromatography method. The separation of both drugs was carried on column like BDS Hypersil C18 (150 x 4.6 mm i.d.) with as 5 p particle size. The ratio of mobile phase for buffer and acetonitrile was 53:47 % (v/v). The 230 nm wavelength was used to record chromatograms. The parameters like linear regression, accuracy, method as well as system precision were studied for validation of method. The parameters like change in wavelength, mobile phase composition and flow rate as per ICH guidelines were studied for robustness. The validation method has been successfully applicable to analyze omeprazole and drotaverine from combined dosage form i.e. tablets.
KEYWORDS: Omeprazole, drotaverine Acetonitrile, tri ethyl amine, ortho phosphoric acid.
INTRODUCTION:
(RS)-6-methoxy-2-((4-methoxy-3, 5-dimethylpyridin-2yl) methyl sulfinyl)-1H-benzo (d) imidazole, Omeprazole is the is a proton pump inhibitor (PPI) in nature. It prevents gastric acid secretion by inhibiting the hydrogen-potassium adenosine triphosphatase at the secretory surface of the gastric parietal cell. [(1 - (3, 4 - diethoxybenzylidene) - 6, 7 - diethoxy - 1, 2, 3, 4 tetrahydroisoquinoline) hydrochloride],Drotaverine hydrochloride is a highly potent spasmolytic drug with smooth muscle relaxant by increasing intracellular levels of cyclic adenosine mono-phosphate (cAMP) secondary to inhibition of phosphor-diesterase.
HPLC1-2, UV spectrophotometric methods3-6 were reported for simultaneous assay of omeprazole and drotaverine hydrochloride in combined dosage form in literature.
This new work presents reproducible reverse phase high performance liquid chromatographic method for simultaneous assay of omeprazole and drotaverine in tablet dosage form.
Chemical and reagents:
As per pharmacopeia, the validated Standards drugs of omeprazole and drotaverine were used . All chemicals of analytical grade were used such as tri-ethyl amine, acetonitrile and ortho phosphoric acid. The HPLC grade water was used from Millipore. For preparation of standard and sample solutions, the diluent was mobile phase i.e. mixture of buffer of pH 4.2 and acetonitrile (53:47 %...