FAST AND SENSITIVE NEW HPLC-UV METHOD FOR DETERMINATION OF OMEPRAZOLE AND MAJOR RELATED SUBSTANCES IN PHARMACEUTICAL FORMULATION

Abstract

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°C, 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 the 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.

Keywords:

• fast and microbore column
• omeprazole
• pharmaceutical formulation
• related substances

ACKNOWLEDGEMENTS

The authors wish to thank Instituto de Investigaciones Cardiológicas Dr. Taquini for providing the HPLC equipment and Dr. Jorge Muse for assistance.

Notes

^a Between OMZ and SFN.

^a Upper and lower case letter represent high and low level of the variable respectively.

Experimental design according to reference^{[ 17 ]}.

^a Critical statistic (Ec = tc (p = 0.05) √2 SD).

^a Results are expressed as mean values (n = 3), RSD values in parenthesis.