Determination of saponins in Xuesaitong Drop Pills and study on batch consistency evaluation techniques / 中草药

ABSTRACT

Objective: To establish the fingerprint of Xuesaitong Dropping Pills (XDP) using ultra-high pressure liquid chromatography (UPLC), determine the content of its main components and propose a chemometrics method for the systemic, comprehensive and scientific quality evaluation. Methods: The Agilent 1290 UPLC and Acquity UPLC BEH C18 column were used for the establishment of the UPLC fingerprints of 14 batches of XDP with acetonitrile and water as mobile phase for gradient elution, and the content of five kinds of notoginsenosides wsa determined. Then, the further quality assessment of XDP was carried out with similarity evaluation, principal component analysis (PCA) and orthogonal partial least squares discriminant analysis (OPLS-DA). Meanwhile, the Hotelling’s T2 and DModX control ranges were set for the different batches of samples. Results: Among the 14 batches, the content of five kinds of notoginsenosides was relatively stable, and the quality control ranges for notoginsenosides R, ginsenoside Rg1, Re, Rb1, Rd were set at 24.69-30.03 mg/g, 102.60-122.44 mg/g, 12.93-15.45 mg/g, 99.74-112.12 mg/g, and 23.35-31.75 mg/g, respectively. In this research, 15 chromatographic peaks were recognized as common peaks in the fingerprints, five peaks were identified with standard references compounds, which were notoginsenoside R1, ginsenoside Rg1, ginsenoside Re,ginsenoside Rb1 and ginsenoside Rd. The similarity values of the drugs were all above 0.998. In the PCA analysis, 14 batches of samples had no abnormal batch, indicating that the quality was relatively stable, however, the difference of the storage time was reflected in the fingerprint. According to the OPLS-DA result, the quantitative ginsenoside Rb1 and ginsenoside Rd had greater influence on the variables causing the gradual trend in 14 batches of samples. The upper limit of control for Hotelling’s T2 and DModX was 31.17 and 1.82, respectively. Conclusion: The established method was accurate, reliable, and simple. It can be used not only for the quality control of XDP, but also for the comprehensive evaluation of batch consistency. The study also provides a reference for solving the common problem of the consistency evaluation of Chinese materia medica.