Analysis of Impurity Profile of Irbesartan and Its Preparations by LC-MS/MS
OBJECTIVE To analyze the impurity profile of irbesartan and its preparations by LC-MS/MS.METHODS ZORB-AX SB-C18 column(4.6 mm × 150 mm,3.5 μm)was used for the separation of the related substances with a mixture of 0.1％formic acid solution(adjusted to pH 3.5 with ammonia)and acetonitrile(62∶38)as the mobile phase by isocratic elution.The structures of the related substances were speculated by ESI-TOF-MS/MS and verified further by reference substances.RESULTS Irbesartan and its related substances were separated under the established chromatographic condition,and a total of 16 related substances were detec-ted.The structures of 10 related substances were verified by reference substances.CONCLUSION The established LC-MS/MS method is effective for separation and identification of the related substances of irbesartan and its preparations,and the results obtained are valuable for its quality control and manufacturing process.
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