Science and Technology Production
Article
Authorship
Date
2010
Publishing House and Editing Place
TAYLOR & FRANCIS INC
Magazine
JOURNAL OF LIQUID CHROMATOGRAPHY AND RELATED TECHNOLOGIES,
vol. 33
(pp. 1666-1678)
TAYLOR & FRANCIS INC
Summary
Information provided by the agent in
SIGEVA
A simple, fast, and sensitive HPLC method with UV detection has been developed for the quantitation of omeprazole (OMZ) and major related substances in raw material and pharmaceutical formulation (paste) using a column of reduced length (50 mm) and diameter (2.1 mm) packed with hybrid particles. Chromatographic conditions were: 25 ºC, 1 µl injection volume and UV detection at WV of 280 nm. The flow rate was 0.3 ml/min using methanol- phosphate buffer (pH 7.6) (40:60) as mobile phase....
A simple, fast, and sensitive HPLC method with UV detection has been developed for the quantitation of omeprazole (OMZ) and major related substances in raw material and pharmaceutical formulation (paste) using a column of reduced length (50 mm) and diameter (2.1 mm) packed with hybrid particles. Chromatographic conditions were: 25 ºC, 1 µl injection volume and UV detection at WV of 280 nm. The flow rate was 0.3 ml/min using methanol- phosphate buffer (pH 7.6) (40:60) as mobile phase. Chromatographic purity was also determined with the same chromatographic conditions. The method was validated according to international guidelines (ICH guidelines) for specificity, linearity, LOD, LOQ, precision, accuracy, and robustness. The HPLC-UV method was found to be suitable for the quality control and stability studies of OMZ in a pharmaceutical formulation.
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Key Words
pharmaceutical formulationfast and microbore columnomeprazolerelated substances