Chinese Journal of Pharmacovigilance ›› 2016, Vol. 13 ›› Issue (1): 16-19.

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Determination of Menthol and Borneol and HPLC Fingerprint in Cangerzi Rhinitis Drop Pills

LIU Meng-ting1, FANG Jing1, TANG Li-ying1, LIU Chong-de2, Fu Mei-hong1, WU Hong-wei1, YANG Hong-jun1   

  1. 1. Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China;
    2.Sichuan Herun Pharmaceutical Co., Ltd, Sichuan Ziyang 641300, China
  • Received:2015-08-12 Revised:2016-02-25 Online:2016-01-08 Published:2016-02-25

Abstract: Objective To establish a method of gas chromatography and the HPLC fingerprint to evaluate the quality of Cangerzi rhinitis drop pills. Methods Using the internal standard method to analyze the content of menthol and borneol in rhinitis dripping pills by gas chromatography. Samples were extracted using methanol and the methodology was established. Ethyl acetate was applied in extracting HPLC fingerprint sample. The detected wave length was 300 nm. The separation was performed with a gradient elution composed of methanol and 0.1% formic acid-water. Results The linear range of menthol was 0.312~0.015 6 mg·mL-1, r=0.999 9, the average recovery was 100.99% (RSD=3.97%, n=6). The linear range of borneol was 0.201 6~0.010 08 mg·mL-1, r=0.999 9, the average recovery rate was 97.61% (RSD=2.09%, n=6). The RSD of precision, repeatability and stability in two components were less than 3%. The concentration of menthol and borneol in Cangerzi rhinitis dropping pills was within the range of 1.34%~2.29% and 1.15%~1.61%, respectively. In the fingerprint, 19 characteristic peaks were established, and three of that were identified. Twenty batches of Cangerzi rhinitis drop pills were determined and the similarities of 18 batches were above 0.95. Conclusion Results show that the method of gas chromatography and fingerprint is convenient,accurate and reliable,which can be applied to control the quality of Cangerzi rhinitis dripping pills.

Key words: Cangerzi rhinitis dripping pills, gas chromatography, fingerprint, quality control, menthol, borneol

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