Quantitative and Qualitative Determination of Impurities in Lansoprazole for Injection / 中国药师

Objective:To establish the method for determining the related substances in lansoprazole for injection and qualitatively study the impurities. Methods:An HPLC method and an HPLC-MS method were used with isocratic elution and DAD as the detector. Results:The priciple impurity in all samples was impurity B. Conclusion:The method is fast, simple and sensitive, and suitable for the determination of the related substances in lansoprazole for injection.