TITLE

A validated, specific, stability-indicating HPLC method for determination of lansoprazole enteric capsules and related impurities

AUTHOR(S)
Yanfei Luo; Lishuang Xu; Ming Xu; Jia Feng; Xing Tang
PUB. DATE
February 2012
SOURCE
Asian Journal of Pharmaceutical Sciences;2012, Vol. 7 Issue 1, p149
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
An isocratic reversed phase high performance liquid chromatographic method with UV detection was developed for the analysis of lansoprazole enteric capsules and related impurities. The mobile phase consisted of pH 6.2 phosphate buffer solution and acetonitrile (65:35, v/v). The UV detection was carried out at 285 nm, and the flow rate was 1.2 ml/min. The separation was carried out on a Dikma Technologies Diamonsil C18 column, 5 μm 250 mm × 4.6 mm, which was maintained at 25°C. LPZ and its related impurities were separated well by this method. This method was validated by stress studies, linearity, limits of detection and quantification, precision and accuracy, stability in solution and robustness. The linear range was 0.5∼1.5 mg/ml. And the test solution was stable in 8 h.The retention time of related impurities was confirmed by their standards. Lansoprazole and impurities E, D, A, B, and C were eluted at about 13.5, 3.0, 3.7, 5.0, 17.5 and 19.5 min, successively. And the resolution of LPZ and related impurities was satisfactory. Consequently, we could conclude that this method was suitable for the analysis of lansoprazole preparations.
ACCESSION #
76385094

 

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