Study on Quality Standard Improvement of Pheretima / 中国药房
China Pharmacy
; (12): 2379-2383, 2019.
Article
in Zh
| WPRIM
| ID: wpr-817144
Responsible library:
WPRO
ABSTRACT
OBJECTIVE: To provide reference for improving the quality standard of Pheretima. METHODS: The contents of hypoxanthine and inosine in medicinal material samples were determined by HPLC. HPLC fingerprint of Pheretima was established according to “Similarity evaluation system for TCM chromatogramtic fingerprint” (2012 edition) software, and similarity evaluation was conducted. The determination was performed on Purospher STAR RP-18 endcapped with mobile phase consisted of methanol-water (gradient elution) at the flow rate of 1 mL/min. The detection wavelength was 248 nm, and the column temperature was set at 30 ℃. The sample size was 20 μL. RESULTS: The results of methodological investigation of content determination showed that the linear range of hypoxanthine and inosine were 1.58-31.6 μg/mL (r=0.999 9), 5.52-110.4 μg/mL(r=0.999 8), respectively. limits of quantify were 0.316, 0.552 μg/mL, respectively; limits of detection were 0.158, 0.110 μg/mL, respectively; RSDs of precision, stability (24 h) and repeatability tests were all less than 2.0% (n=6). Average recovery rates were 103.0% (RSD=1.7%, n=6) and 101.2% (RSD=1.2%, n=6), respectively. HPLC fingerprint for 15 batches of samples were established, and 8 common peaks were identified. The similarity of HPLC fingerprint of 14 batches of sample with control fingerprint R was higher than 0.900. CONCLUSIONS: The established method for content determination of hypoxanthine and inosine and HPLC fingerprint of Pheretima are simple, accurate and reproducible, and can be used for quality control of Pheretima.
Full text:
1
Database:
WPRIM
Language:
Zh
Journal:
China Pharmacy
Year:
2019
Document type:
Article