RESUMO
Objective:To determine the content of self-manufactured and imported lurasidone hydrochloride tablets in order to e-valuate their internal qualities. Methods:The determination of lurasidone hydrochloride tablets was performed by HPLC. The HPLC system consisted of a Waters C8 column (250 mm × 4. 6 mm, 3. 5 μm) and the mobile phase of 0. 05 mol·L-1 phosphate buffer solu-tion (pH 3. 0)-acetonitrile(60∶40), the detection wavelength was 230 nm, the flow rate was 1. 2 ml·min-1 and the column tempera-ture was 40℃, and the injection volume was 20μl. Results:The linear range of lurasidone hydrochloride was 0. 100 8-0. 806 4 mg· ml-1(r=0. 999 5). The average recovery was 99. 95% with RSD of 0. 31%(n=9). Conclusion:The method is simple, rapid, ac-curate, and reliable. The method can determine lurasidone hydrochloride tablets satisfactorily. According to the results, there are few differences among the self-manufactured and imported lurasidone hydrochloride tablets.
RESUMO
Objective:To improve the TLC identification method in the quality standard for Yangyin Qingfei granules by identifying paeoniflorin and radix scrophulariae on the same condition plate. Methods:The preparation method for paeoniflorin sample solution in the original standard of TLC identification was improved, the extraction method was water-saturated n-butanol extraction, and the reference crude herb solution of radix scrophulariae was prepared. Simultaneous TLC identification of paeoniflorin and radix scrophular-iae was carried out according to the method described in the original standard. Results:The improved TLC method could be used in the simultaneous identification of paeoniflorin and radix scrophulariae, the spots were clear, and the separation and reproducibility were promising without interference. Conclusion:The improved method is more useful in the quality control of the product with simplified operation.