A validated, stability-indicating, LC method for rabeprazole sodium

作者：Buchireddy Reguri; Mukkanti Khagga; Srinivasulu Polisetty; Srinivas Koduri S V^*

来源：Chromatographia, 2008, 68(3-4): 275-280.

DOI：10.1365/s10337-008-0670-y

• column liquid chromatography
• reversed phase
• rabeprazole sodium
• impurities
• degradation products
• validation

A simple, economic, and time-efficient stability-indicating, reversed-phase high-performance liquid chromatographic method has been developed for analysis of rabeprazole in the presence both of impurities and of degradation products generated by decomposition. When rabeprazole was subjected to acid hydrolytic, oxidative, photolytic, and thermal stress, degradation was observed after acid hydrolysis, oxidation, and aqueous hydrolysis. The drug was found to be stable to other stress conditions. Successful chromatographic separation of the drug from impurities formed during synthesis and from degradation products formed under stress conditions was achieved on a C-8 column with water-acetonitrile-triethylamine 55:45:0.25 (v/v), pH adjusted to 6.9 with trifluoroacetic acid, as mobile phase. The method was validated for linearity, accuracy, precision, specificity, and robustness and can be used for quality-control during manufacture and for assessment of the stability of samples of rabeprazole sodium. To the best of our knowledge, a validated stability-indicating LC method which separates all the impurities studied in this investigation has not been published elsewhere.

• 出版日期2008-8