ABSTRACT
Objective To establish a HPLC method for quality control of Pei-bao capsule. Methods The content of lysine derivatized from 2,4-dinitoflruorobenzene was determined by HPLC, with chromatographic column being the agilent Zorbax SB-C18 column (250 mm×4.6 mm, 5 μm) , mobile phase being acetonirile-0.04mol/L, potassium dihydrogen phosphate (40 : 60), the flow rate being 1.0 ml/min, the column temperature being 30 ℃, and wavelength being 360 nm. Results It showed good linear coorelation when the concentration of Lysine hydrochloride being within 0.39～ 19.3μg/ml (γ =0.9999) , and the average sample recovery rate was 100.2%. Conclusion This method is simple, accurate, stable and reliable. It can be used for quality control of Pei-bao capsule.
ABSTRACT
Object To study the different fingerprints of hydrophilic and hydrophobic components in roots of Salvia miltiorrhiza Bge. collected from different habitats, and discovery the relationship between the two types of components. Methods The fingerprints were detected by RP-HPLC and the results were analyzed by SPSS software. Results Roots of S. miltiorrhiza collected from different habitats showed different fingerprints of hydrophilic and hydrophobic components, there is no obvious relationship between the two types of components. Conclusion In order to control the quality of 5. miltiorrhiza roots that is used to manufacture injections, we must assay the hydrophilic components, such as salvianolic acid B should be determinded.
ABSTRACT
AIM: To identify an unknown peak in Guanxinning Injection(Radix et Rhizome Salviae Miltiorrhizae,Rhizoma Chuanxiong) chromatographic fingerprint. METHODS: The elution(44-46 min) separated and collected by HPLC was analyzed by GC-MS and HPLC-PDA-MS-MS. RESULTS: The unknown peak was corresponding to senkyunolidel I. CONCLUSION: It is quick method to identify the reported chemical in herbal medicine based on a small quantity of sample by GC-MS and HPLC-PDA-MS-MS.
ABSTRACT
Objective: To discuss the method for establishing the relationship between chromatographic fingerprints and its usage in process control. Methods: The relationship between chromatographic fingerprints of a fermentation product Ganoderma capense and its finished preparation had been developed according to guidance on fingerprint of Chinese traditional medicinal medica. As for peaks whose acceptance criteria of relative area should be set, their relative areas in chromatographic fingerprints of raw material and its finished product, the ratios of relative areas of peaks from raw material to those from finished product and their relative standard differences were calculated. Results: The relative standard differences of the rations of all peaks whose acceptance criteria areas should be set, were less than 8%. Conclusion: The results show that the rations and RSDs are enough to represent the quantitave relationship between chromatographic fingerprints, and the acceptance criteria of RSD should be less than 10% (n≥10). The quality of finished product can only be assured if the acceptance criteria of relative areas of peaks in chromatographic fingerprint of raw material are tighter than those set according to guidance, and the manufacture process keeps consistency.
ABSTRACT
Objective: To establish a HS CGC method for the analysis of residual petroleum ether (60～90?C) in Kanglaite Capsules.Methods: Headspace sampling, a fused silica analytical column with cross linked 95% dimethyl and 5% diphenyl siloxanes station phase (30m?320?m?0.25?m), column temperature at 40?C, a linear velocity of about 19 cm per second, FID detector.Results: The average recovery is 97.2% (RSD=2.87%, n=5). The minimal detection limit is 2.65?10 -8 g?mL -1 (signal/noise=1.3).Conclusion: The method is simple and accurate, and can be used as a control method for the residual organic solvent in the capsules.