ABSTRACT
OBJECTIVE: To propose a holistic strategy for quality control of Chinese patent medicines, and establish an HPLC analytical method for Tongzhi Surunjiang preparation according to the strategy. METHODS: The strategy contained three steps.The first step was multi-wavelength chromatographic detection.The second step was multivariate analysis for identification and assay. The third step was to establish substitute reference substance method.The preparations were extracted by ultrasound with methanol, chromatography was performed on ODS column with gradient elution with acetonitrile and 0.1%phosphoric acid aqueous solution.The detection wavelengths were set at 270, 350, 410 and 440 nm.The radar chart, HCA heatmap, principal component analysis and cosine similarity were used for data analysis.At last, linear calibration using two reference substances, relative retention time method and PDA spectrum method were used for peak identification, and relative correction factor method was used for quantitative analysis. RESULTS: The multi-components determination method and fingerprint analysis met the method validation requirements. Data analysis showed that there were some differences among the samples of different manufacturers. Strong characteristic peaks for classification were gallic acid, chebulinic acid, chebulea fructus, sennae folium, sennae folium and crocin.CONCLUSION: The method is specific, with low cost, and could be used to accurately control the quality of Tongzhi Surunjiang preparation.
ABSTRACT
OBJECTIVE: To establish the HPLC fingerprint of Swertia chirayita, and validate the feasibility of the double standard linear correction method using two reference substances with PDA assistance. METHODS: The fingerprint of Swertia chirayita was established by HPLC, and similarity analysis and two-dimensional clustering analysis were used for quality evaluation. Linear calibration using two reference substances with PDA assistance was used for identification of chromatographic peak. RESULTS: Ten chromatographic peaks were selected as common peaks in the fingerprint of 10 batches of Swertia chirayita. Preliminary evaluation of the quality was made by chemometrics evaluation. The precision of predicting retention time by linear calibration using two reference substances was superior to the relative retention time method. Linear calibration using two reference substances with PDA assistance could qualify the chromatographic peaks better. CONCLUSION: Linear calibration using two reference substances is more accurate and suitable for more chromatographic columns than relative retention time method. PDA assistance can enlarge the scope of application of linear calibration using two reference substances.
ABSTRACT
Substitute reference substance method is an effective approach for quality control of multiple components in accordance with the characteristics of traditional Chinese medicines. The purpose of the guideline is to guide the establishment of substitute reference substance method, prove the conformance of the method to the requirements for testing, and standardize the study method and its application in national drug standards. The topics of the guideline include the definition and classification of substitute reference substance method, the principles and approaches of quantitative analysis, the identification and confirmation of chromatographic peaks, and technical requirements. When substitute reference substance method is used for fingerprint identification or multiple components assay in traditional Chinese medicines, the analytical method can be validated following the guideline.
ABSTRACT
OBJECTIVE: To establish the HPLC fingerprint of Semen Strychni by chemometrics and the method of linear calibration using two reference substances (LCTRS). METHODS: The fingerprint of Semen Strychni was established by HPLC, using similarity analysis, 2-dimensional clustering analysis and principal component analysis for quality evaluation. LCTRS was used for identification of chromatographic peak. RESULTS: Fourteen chromatographic peaks were selected as common peaks in the fingerprints of 10 batches of Semen Strychni, and the chromatographic peaks of loganic acid, chlorogenic acid, strychnine and brucine were selected as characteristic peaks. By means of chemometrics evaluation, 10 batches of Semen Strychni were classified by their origins. The precision of predicting retention time by LCTRS was superior to the relative retention time method. CONCLUSION: LCTRS is more accurate for predicting retention time and suitable for more kinds of chromatographic columns than relative retention time method. In addition, the established fingerprint is specific, and can be used for the quality evaluation of Semen Strychni.