Fast and Sensitive New HPLC-UV Method for Determination of Omeprazole and Major Related Substances in Pharmaceutical Formulation

FLOR S.,; TRIPODI V.,; SCIOSCIA S.,; REVELLO L.; LUCANGIOLI SILVIA

JOURNAL OF LIQUID CHROMATOGRAPHY AND RELATED TECHNOLOGIES

TAYLOR & FRANCIS INC

Lugar: Boca Raton; Año: 2010 vol. 33 p. 1666 - 1678

1082-6076

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.