HPLC法测定盐酸鲁拉西酮片的含量

目的：建立含量测定方法,考察自制盐酸鲁拉西酮片与进口片的含量,评价其内在质量。方法：采用高效液相色谱法测定盐酸鲁拉西酮片的含量,以Waters C8（250 mm×4.6 mm,3.5μm）为色谱柱,以0.05 mol·L-1磷酸盐缓冲液（pH 3.0）-乙腈（60∶40）为流动相,检测波长为230 nm,流速为1.2 ml·min-1,柱温为40℃,进样量为20μl。结果：盐酸鲁拉西酮的线性范围为0.100 8~0.806 4 mg·ml-1（r=0.999 5）,平均回收率为99.95%,RSD=0.31%（n=9。结论：该测定方法简便、快速、准确、可靠,能理想地测定盐酸鲁拉西酮片中盐酸鲁拉西酮的含量,自制产品与进口产品含量基本一致。

Determination of Lurasidone Hydrochloride Tablets by HPLC

Objective： To determine the content of self-manufactured and imported lurasidone hydrochloride tablets in order to evaluate their internal qualities. Methods： The determination of lurasidone hydrochloride tablets was performed by HPLC. The HPLC system consisted of a Waters C8column（ 250 mm × 4. 6 mm,3. 5 μm） and the mobile phase of 0. 05 mol·L- 1phosphate buffer solution（ pH 3. 0）-acetonitrile（ 60∶ 40）,the detection wavelength was 230 nm,the flow rate was 1. 2 ml·min- 1and the column temperature was 40℃,and the injection volume was 20 μl. 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,accurate,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.