AIM:A new method for the overall quality control of Radix Scutellariae has been established by HPLC digitized fingerprint. METHODS: The chromatographic fingerprints were obtained from injecting 5 ?L of the sample solution each time on a CenturySIL C_(18) BDS column(200 mm?4.6 mm,5 ?m) with the gradient elution solvent system composed of 1% acetic acid water and 2% acetic acid acetonitrile.The flow rate was 1 mL/min,the column temperature was maintained at(30?0.15)(?C) and the detection wavelength was set at 280 nm.The chromatographic fingerprints were evaluated by the software of the digitized evaluation system of Traditional Chinese Medicine fingerprint with the super information characteristics. RESULTS: 30 co-possessing peaks were selected as the fingerprint peaks of Radix Scutellariae and the similarities between the chromatographic fingerprints and the herbal drugs were calculated by taking baicalin peak as the referential peak.The chromatographic fingerprints were also evaluated by the chromatographic fingerprint index(F). CONCLUSION: This method with good precision and reproducibility can be applied to the quality control of Radix Scutellariae.

This study was aimed to establish an analytical method to determine spinosin, jujuboside A, jujuboside B and betulinic acid content of Ziziphi Spinosae Semen quickly and accurately. The UPLC determination of Ziziphi Spinosae Semen method was established on an HSS T3 Column (2.1 mm × 100 mm, 1.8 μm) eluted with the mobile phase consisted of water containing 0.03% phosphoric acid and acetonitrile in gradient mode with the flow rate of 0.5 mL?min-1 and the detection wavelength was set at 204 nm. The standard curves of spinosin, jujuboside A, jujuboside B, betulinic acid showed a good linearity in 29.70 - 594.0 μg?mL-1, 10.68 - 213.6 μg?mL-1, 6.175 - 123.5 μg?mL-1, 22.00 - 440.0 μg?mL-1, respectively. The mean recoveries (n = 9) of the four components were between 98 . 3% and 99 . 4%, RSD < 1 . 4%. This method which is quick and accurate can be used to determine spinosin, jujuboside A, jujuboside B and betulinic acid in Ziziphi Spinosae Semen.

Larotaxel, a new taxane compound prepared by partial synthesis from 10-deacetyl baccatin Ⅲ, is active against tumors. In this research, a selective LC–MS method was developed and validated for the study of degradation kinetics of larotaxel, which was carried out in aqueous solutions with different pH (1.5, 3.0, 5.0, 6.5, 7.4, 9.0, 10 and 11.0) and temperature (0, 25, 37 and 45 °C). The linear range was 0.5–25μg/mL, the intra-and inter-day precisions were less than 7.0%, and accuracy ranged from 97.4–104.5% for each analyte. The observed rate obtained by measuring the remaining intact larotaxel was shown to follow first-order kinetics. The activation energies for degradation were 126.7 and 87.01 kJ/mol at pH 1.5 and 11, respectively. Although larotaxel was stable in pH 5, 6.5 and 7.4 buffers at 37 °C for 24 h during our study, increasing or decreasing the pH of the solutions would decrease its stabilities. Moreover, three main degradation products in alkaline condition were separated by HPLC and identified by Q–TOF–MS. The three degradation products were confirmed as 10-deacetyl larotaxel, 7, 8-cyclopropyl baccatin Ⅲ and 10-deacetyl-7, 8-cyclopropyl baccatin Ⅲ.

Related substances in pharmaceutical formulations are associated with their safety, efficacy and stability. However, there is no overall study already published on the assessment of related substances in the Compound Ketoconazole and Clobetasol Propionate Cream. In this work, a reliable HPLC-TOF-MS qua-litative method was developed for the analysis of related substances in this preparation with a quick and easy extraction procedure. Besides the active pharmaceutical ingredients, two compounds named ke-toconazole impurity B′ optical isomer and ketoconazole impurity E were identified. Furthermore, a new HPLC method for qualitative and quantitative assessment on related substances and degradation pro-ducts, which were found in the stability test, was established and validated. The single standard to determine multi-components method was applied in the quantitative analysis, which was an effective way for reducing cost and improving accuracy. This study can provide a creative idea for routine analysis of quality control of the Compound Ketoconazole and Clobetasol Propionate Cream.