Test of chemical dyes and quantitative determination of dracorhodin perchlorate in Guanmaining tablets / 中国药学杂志

ABSTRACT

OBJECTIVE: To establish methods for the test of chemical dyes and quantitative determination of dracorhodin perchlorate in Guanmaining tablets. METHODS: HPLC-UV-MS/MS was used for the test of chemical dyes in Guanmaining tablets, and the concentration of dracorhodin perchlorate was determined by HPLC. In the test of chemical dyes, Agilent Zorbax-SB C18 (4.6 mm × 250 mm, 5 μm) was used as stationary phase, the mixture of 0.02 mol · L-1 ammonium acetate and acetonitrile was used as mobile phase in gradient elution mode, and the UV-Vis detection wavelength was set at 520 nm. ESI+ was used as ion source, and the MS/MS spectra of the analytes were recorded to confirm the positive results. In the quantitative analysis of dracorhodin perchlorate, Phenomenex Luna C18(4.6 mm × 250 mm, 5 μm) was used as stationary phase, the mixture of acetonitrile and 0.05 mol · L-1 sodium dihydrogen phosphate solution (3763) was used as mobile phase, and the detection wavelength was set at 440 nm. RESULTS: Among 56 batches of Guanmaining tablets, 7 batches showed positive results of sudan I, sudan IV, and/or 808 scarlet. A good linear relationship was obtained in the range of 0.408 0 - 816.6 μg · mL-1 for dracorhodin perchlorate, with the linear regression equation of y = 1.746 1 × 107ρ +2 419.9(r = 1.000 0); the average recovery was 98.37% (RSD = 1.2%, n =6). The content of dracorhodin perchlorate in Guanmaining tablets ranged from 0.01 to 0.25 mg · tablet-1. CONCLUSION: The method is simple, accurate and rapid, and can be used for the quality control of Guanmaining tablets.