Abstract
Objective: During the preparation of Zishen Yutai Pills, 5-Hydroxymethylfurfural may be used. To establish a HPLC method for determination of 5-HMF in Zishen Yutai pill and to provide the potential quality control standard of it. Methods: RP-HPLC method was applied with the chromatographic condition as follows: the chromatographic column was Phenomenex Gemini C18 column (250×4.6mm, 5μm), methanol-water (10:90) as the mobile phrase, the flow rate was 0.8mL/min, the detection wavelength was 284nm, the column temperature was 30°C, and the injection volume was 10μL. Results: The calibration curve was linear in the range of 2.16~43.27μg. mL<sup>-1</sup> for 5-HMF (r<sup>2</sup>=0.9993). The RSD of the method repeatability was 0.97% (n=6) and the average recovery was 99.4% (RSD=0.58%). What’s more, the specificity, precision and stability results were also good. Conclusion: The method for HPLC is not only sensitive and accurate. It is also easy to operate which can be used as the determination method for 5-HMF and has a guiding role for the quality control of the Zishen Yutai pill.
Highlights
Zishen Yutai pill (ZYP) is a traditional Chinese medicine compound preparation containing 15 Chinese herbal medicines
There are related literature reports that the daily allowable intake of 5-hydroxymethyl furfural is 30-60 mg, and foreign literature reports that the intake of 5-HMF is 1.6-150 mg/person/day
5-hydroxymethyl furfural reference substance was purchased from National institues for food and drug control (Lot Number: 111626-201509) and ZYP was from Guangzhou Zhongyi Pharmaceutical Company (Lot Number: S00033, T00058, T00061, Guangzhou, China)
Summary
Zishen Yutai pill (ZYP) is a traditional Chinese medicine compound preparation containing 15 Chinese herbal medicines. It has been reported that it can enhance the receptivity of the endometrium, prevent re-abortion, and enhance the spleen and kidney function It is an effective medicine for the treatment of menstrual disorders with luteal phase deficiency, asthenospermia and spleen and kidney deficiency type infertility [2, 3]. The 5-HMF content of Rehmannia glutinosa after processing will increase about 20 times. According to reports in the literature, larger doses can damage human striated muscle and internal organs [4]. It is neurotoxic and can combine with human proteins to produce accumulated poisoning [5] and abnormal growth of colonic sac [6], which seriously affects the health of patients taking the drug. The establishment of a high performance liquid chromatography determination method aims to provide a reference for the quality control of the drug
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