HPLC fingerprint of Xintongtai Granules / 中草药

ABSTRACT

Objective: To establish an HPLC method for fingerprint analysis of Xintongtai Granules (XG) for its quality control. Methods: The chromatographic behaviors were obtained by a Phenomenext Luna C18 column (250 mm × 4.6 mm, 5 μm) with gradient elution using 0.1% formic acid solution-methanol as the mobile phase. The detection wavelength was 280 nm, the volume flow rate was 1.0 mL/min, and the column temperature was 30 ℃. The samples of 10 batches of XG were determined, and the chromatographic fingerprint similarity evaluation system of Chinese medicine (2012 edition) was used to establish the common pattern of XG fingerprints, and the similarity was calculated. Then the common peaks were identified by the reference chromatogram. Results: HPLC fingerprints of XG were established by the determination of 10 batches of samples. The similarity was above 0.95. A total of 26 common peaks were calibrated. Three mutual peaks (No. 21, 22, 26 peaks) were from Salviae Miltiorrhizae Radix et Rhizoma, eight mutual peaks (No. 4—10, 16 peaks) were from Puerariae Lobatae Radix, seven mutual peaks (No. 13, 15, 17—20, 23 peaks) were from Aurantii Fructus, No. 12 peak was from Chuanxiong Rhizoma, No. 14 peaks was from Glycyrrhizae Radix et Rhizoma, No. 1 peak was shared by Notoginseng Radix et Rhizoma and Glycyrrhizae Radix et Rhizoma, No. 2 peaks was shared by Notoginseng Radix et Rhizoma, Aucklandiae Radix, and Crataegi Fructus, No. 3 peaks was shared by Chuanxiong Rhizoma and Aucklandiae Radix, No. 11 peaks was shared by Puerariae Lobatae Radix and Curcumae Radix, the No. 24 peaks was shared by Chuanxiong Rhizoma and Aurantii Fructus, and No. 25 peaks was shared by Curcumae Radix and Aurantii Fructus. The common peaks were all assigned to each medicinal material and identified by reference chromatograms No. 7, 12, 22, and 26 peaks were puerarin, ferulic acid, salvianolic acid B, and tanshinone IIA. Conclusion: The similarity results of 10 batches of samples indicate that the particle preparation process is stable and feasible, and the established HPLC fingerprint method is stable and reliable. It can be used to measure the stability of XG production process and the controllability of finished product quality.