Study of Related Substances in Omeprazole Enteric-coated Capsules
s:Objective:To establish an HPLC method for the simultaneous determination of nine impurities in omeprazole enteric-coated capsules,and to provide a basis for the quality control of omeprazole enteric-coated capsules.Methods A Waters Xbrige C8(150×4.6 mm,5 μm)was used for the simultaneous determination of the nine substances in omeprazole enteric-coated capsules by HPLC using glycine-sodium glycinate buffer solution(pH 9.00)as the A-phase and acetonitrile-methanol(85∶15,v/v)as the B-phase,with a gradient elution.The detection wavelength was 305 nm,the column temperature was 30℃,the injection volume was 10 μL,and the flow rate was 1.2 mL/min.Results Under the chromatographic conditions,the main peak of omeprazole and each impurity could be effectively separated.The method was highly specific,with good linearity in the range of 0.03 μg/mL～2.00 μg/mL for each impurity(r＞0.9990 for each impurity);the recoveries were in the range of 80%～120%(RSD were less than 5%);the impurity contents of the three batches of samples were detected:impurities C and D were detected,and the contents of each were less than 0.09%;impurities A,E,and F&G,and the contents were less than 0.02%.The total impurities were between 0.15%and 0.20%.Conclusion This method is simple,accurate,reproducible and highly sensitive,and can be effectively used for the examination and content determination of 9 impurities in omeprazole enteric capsules.
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