M. Mathew et al., STABILITY OF OMEPRAZOLE SOLUTIONS AT VARIOUS PH VALUES AS DETERMINED BY HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY, Drug development and industrial pharmacy, 21(8), 1995, pp. 965-971
A stability-indicating HPLC assay method for the quantitation of omepr
azole has been developed. The developed method was used to study the e
ffect of pH on the stability of omeprazole and to quantify the drug in
capsules. The excipients present in the capsules did not interfere wi
th the assay procedure. The pH-rate profile curve indicated that the m
aximum stability was at pH 11. Below pH 7.8, the decomposition was ver
y fast. The decomposition constants have a direct relationship with th
e H+ concentrations of the solutions.