Establishment of the fingerprint of Temurin- 5 powder and content determination of 4 components / 中国药房

ABSTRACT

OBJECTIVE To establish the fing erprint of Temurin- 5 powder，conduct chemical pattern recognition analysis ，and determine the contents of 4 components simultaneously. METHODS The fingerprints of 10 batches of Temurin- 5 powder were established and similarity evaluation was performed by using high performance liquid chromatography （HPLC）combined with the Similarity Evaluation System of Chromatographic Fingerprints of Traditional Chinese Medicine （2012 edition）；common peaks were identified by comparing with mixed substance control. The common peaks were analyzed by systematic cluster analysis and principal component analysis with SPSS 26.0 software. The HPLC method was used to determine the contents of gallic acid ， geniposide，chlorogenic acid and ellagic acid in 10 batches of samples. RESULTS A total of 15 common peaks were identified from the fingerprints of 10 batches of Temurin-5 powder，and the similarity was 0.997-0.999. It was identified that peak 1 was gallic acid ，peak 3 was geniposide ，peak 5 was chlorogenic acid and peak 12 was ellagic acid. Among the 10 batches of samples ， S4 and S 9 were grouped into one category ，S6-S8 were grouped into one category ，and the other batches of samples were grouped into one category. The accumulative variance contribution rate of first three principal components was 89.245％. The linear ranges of gallic acid ，geniposide，chlorogenic acid and ellagic acid were 5.55-177.5，15.98-511.5，2.56-82.0 and 13.48-431.5 μg/mL， respectively. RSDs of precision ，stability（24 h）and repeatability tests were all less than 2％（n＝6 or n＝7）. The average recoveries were 101.56％，102.21％，98.60％ and 96.62％，respectively，RSDs were 1.90％，1.61％，1.58％ and 1.73％（n＝6）. Average contents of above components were 5.03-5.64，10.38-12.16，1.40-1.69，6.47-7.11 mg/g，respectively. CONCLUSIONS The established fingerprint is stable and feasible ，and the content determination method meets the relevant regulations. Combined with chemical pattern recognition analysis ，it can be used for the quality control of Temurin- 5 powder.