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ABSTRACT:
A simple, accurate, precise, and specific UV-Vis spectrophotometric simultaneous equation method has been developed for simultaneous determination of famotidine and dicyclomine HCl in its combined tablet dosage form by using methanol as a solvent. The proposed simultaneous equation method involves measurements of wavelength selected at 292 nm for famotidine and 218 nm for dicyclomine HCl. The linearity was found to be in the range of 20-120 pg/ml and 50-100 pg/ml for famotidine and dicyclomine HCl respectively. Beer's law was obeyed in this concentration range with correlation coefficient of 0.998 and 0.999 for famotidine and dicyclomine HCl respectively. The repeatability, Intra-day precision, Interday precision % RSD were found to be 0.140, 0.1305, 0.167 for famotidine and 0.180, 0.0321, 0.0472 for dicyclomine HCl respectively. Limit of detection and quantification was found to be 0.6944 pg/ml and 2.1044pg/ml for famotidine and 0.4446pg/ml for and 1.3474pg/ml for dicyclomine HCl respectively. Assay results for marketed formulation were found to be 98.91% and 101.83% for famotidine and dicyclomine HCl respectively. The proposed method has been validated as per ICH guidelines and successfully applied to the estimation of famotidine and dicyclomine HCl in their combined dosage form.
KEYWORDS: Famotidine, Dicyclomine Hydrochloride, Simultaneous equation method, UV Spectrophotometry and Forced degradation study.
1.INTRODUCTION:
Famotidine is an antiulcer drug and is chemically N(aminosulfonyl)-3-[[[2-[(diaminomethylene) amino]-4thiazolyl] methyl] thio] propanimidamide.1 Famotidine is potent histamine (H2)-receptor antagonist that binds to the H2 receptor in a competitive reversible. The H2RAs are reversible, competitive antagonists at histamine type2 2 primarily on the parietal cells within the gastrointestinal mucosa2.
It is official in and European Pharmacopoeia.3A literature survey revealed there is UV spectrophotometry, HPLC, HPTLC4-9 methods for estimation of Famotidine in Pharmaceutical formulation. Dicyclomine hydrochloride is an anticholinergic drug and is chemically [Bicyclohexyl]-1-carboxylic acid, 2(diethyl amino) ethyl ester hydrochloride which shows beneficial effects on anticholinergic effect (antimuscarinic) at the acetylcholine-receptor sites and second is a direct effect upon smooth muscle (musculotropic).10 A literature survey revealed that RPHPLC11-14method for the estimation of Dicyclomine Hydrochloride in Pharmaceutical formulation. The chemical structures of both drugs are shown in given figures. 1
The review of literature stated that various analytical methods involving spectrophotometry, HPLC, and HPTLC have been reported for famotidine in single form and in combination with other drugs. Several analytical methods have...