Stability-indicating HPLC–DAD methods for determination of two binary mixtures: Rabeprazole sodium–mosapride citrate and rabeprazole sodium–itopride hydrochloride

Abstract

Two selective stability-indicating HPLC methods are described for determination of rabeprazole sodium (RZ)–mosapride citrate (MR) and RZ–itopride hydrochloride (IO) mixtures in the presence of their ICH-stress formed degradation products. Separations were achieved on X-Bridge C18 column using two mobile phases: the first for RZ–MR mixture consisted of acetonitrile: 0.025 M KH2PO4 solution: TEA (30:69:1 v/v; pH 7.0); the second for RZ–IO mixture was at ratio of 25:74:1 (v/v; pH 9.25). The detection wavelength was 283 nm. The two methods were validated and validation acceptance criteria were met in all cases. Peak purity testing using contrast angle theory, relative absorbance and log A versus the wavelengths plots were presented. The % recoveries of the intact drugs were between 99.1% and 102.2% with RSD% values less than 1.6%. Application of the proposed HPLC methods indicated that the methods could be adopted to follow the stability of their formulations.

Development of Validated Stability-indicating High Performance Thin Layer Chromatography Method for Estimation of Rabeprazole Sodium and Aceclofenac in Bulk Drug

“…Stability study of RZL and ACF demonstrated satisfactory results. The type of degraded product formed, R f value and the percent drug recovery variation showed the differences from the results reported in literature for drug degradation by other analytical methods [17,[19][20] because of the nature, methodology and extent of degradation. The study activity was limited till the formation of chromatogram of degraded drug sample, its approximate interpretation, nevertheless there is a scope for the separation, quantification and analysis of the degraded products.…”

“…Although, various analytical techniques has been developed for estimation of RZL and ACF individually or with other components in bulk drug and pharmaceutical dosage forms, the most suitable, efficient and cost effective HPTLC method has not yet been determined [15][16][17][18][19][20][21][22][23] Similarly, this technique has not been used for stability indication of drugs so far. It requires modification depending on the factors that predict the better resolution, validation within accepted limits and clear separation from degradation products.…”

Simultaneous Estimation of Lansoprazole and Domperidone in Tablet Dosage Form by Rp-HPLC

“…Literature survey reveals that there are methods to analyse these drugs by spectroscopic methods [3][4], in tablet [5][6][7][8][9][10][11][12][13][14][15][16], in plasma [17][18].There are no methods reported in tablets using Buffer and Acetonitrile as solvent which is cost effective.…”

“…It speeds gastrointestinal peristalsis, causes prolactin release, and is used as antiemetic and tool in the study of dopaminergic mechanisms. Lansoprazole chemically is 2-({[3-methyl-4-(2, 2, 2-trifluoroethoxy) pyridin-2-yl] methane} sulfinyl)-1H-1, 3-benzodiazole and used as a proton pump inhibitor which prevents the stomach from producing acid [1-2].Literature survey reveals that there are methods to analyse these drugs by spectroscopic methods [3][4], in tablet [5][6][7][8][9][10][11][12][13][14][15][16], in plasma [17][18].There are no methods reported in tablets using Buffer and Acetonitrile as solvent which is cost effective.Hence an attempt is made to develop simple, Accurate and Precise and cost effective method [19][20] for simultaneous estimation of Lansoprazole and Domperidone by RP-HPLC in tablet dosage form according to ICH guidelines [21].…”