Simultaneous Determination of 4 Components in Xinyi Biyan Pills by HPLC-switching Wavelength Method / 中国药房

ABSTRACT

OBJECTIVE: To establish the method for simultaneous determination of pim-O-glucosylcimifugin, liquiritin, 5-0-methylvisammioside and amonium glycyrrhizinate in Xinyi byan pills.METHODS: HPLC-switching wavelength method was used for content determination of 52 batches of Xinyi byan pills sample from enterprises A, B, C. The determination was performed on Kromasil C18 column with mobile phase consisted of acetonitrile-0. 1 ％ phosphoric acid at the flow rate of 1. 0 mL/min. The detection wavelengths were set at 220 nm (pim-O-glucosylcimifugin, liquiritin, 5-O-methylvisammioside) and 250 nm (amonium glycyrrhizinate). The column temperature was 30℃, and sample size was 10 μ L. RESULTS: The linear ranges of prim-O-glucosylcimifugin, liquiritin, 5-O-methylvisammioside and amonium glycyrrhizinate were 6. 138-122. 77 μg/mL (r=0. 999 9), 2. 502-50. 03 μg/mL (r=0. 999 9), 5. 988-119. 75 μg/mL (r=0. 999 9) and 12. 788-255. 76 μg/mL (r=0. 999 9), respectively. RSDs of precision, stability and reproducibility tests were all lower than 2. 0％ (n=6). The recovery rate were 100. 32％ (RSD=0. 58％, n=6), 100. 24％ (RSD=0. 56％, n=6), 101. 28％ (RSD=0. 91％, n=6) and 101. 48％ (RSD=0. 79％, n=6), respectively. Total contents of 4 components in enterprise A were generally higher than enterprises B, C, among which the difference of liquiritin was significant; the content of prim-O-glucosylcimifugin in enterprise B was higher than enterprises A, C, while the content of 5-O-methylvisammioside was lower than enterprises A, C. The content of liquiritin in enterprise B was outlier. CONCLUSIONS: This method is simple, reproducible and can provide reference for quality control of Xinyi biyan pills.