Determination of Principal Compound and Related Substances in Raw Material Drug of Menaquinone-7 by UPLC

Raw material drug of Menaquinone-7 was dissolved ultrasonically with ethanol in the dark, and then the principal compound and related substances in the sample were separated on an Agilent Eclipse plus C₁₈ chromatographic column (2.1 mm×50 mm, 1.8 μm). The mobile phase was methanol-water (98+2) solution, and the detection wavelengths were 246, 270 nm for the determination of principal compound and related substances, respectively. The linearity range of Menaquinone-7 was 0.005-0.400 g·L^-1, with detection limit (3S/N) of 0.1 mg·L^-1. Recovery rates obtained by standard addition method were in the range of 98.8%-100% and RSDs (n=6) were less than 1.0%. The contents of the principal compound in 2 batches of Menaquinone-7 raw material drug were 98.0% and 98.2%. The mass fraction of single impurity was less than 0.5%, and the mass fraction of total impurities was less than 1.0%.