目的 建立HPLC法测定氯氮平片中有关物质。方法 采用Hypersil BDS色谱柱（200 mm×4.6 mm，5 mm）；流动相为1 mol/L冰醋酸-[甲醇-乙腈（1∶1）]，梯度洗脱；检测波长为257 nm；体积流量为1.2 mL/min；柱温为25 ℃；进样体积为20 mL。结果 氯氮平、氯氮平N-氧化物、杂质A、杂质B、杂质C、杂质D分别在0.075～15.000、0.076～15.200、0.076～15.200、0.076～15.200、0.076～15.200、0.122～24.400μg/mL线性关系良好，平均回收率分别为95.42%、95.72%、95.44%、96.56%、103.48%、104.37%，RSD值分别为0.78%、0.92%、0.57%、0.65%、1.03%、1.77%。结论 建立了氯氮平片中有关物质检查的HPLC法，简便、准确、专属性强，适用于氯氮平片的质量控制。

Objective To establish an RP-HPLC method for determination of related substances in Clozapine Tablets. Methods Hypersil BDS C₁₈ column (200 mm × 4.6 mm, 5 mm) was adopted. Mobile phase was 1 mol/L acetic acid solution - [methanol - acetonitrile (1∶1)] with gradient elution. Detection wavelength was set at 257 nm, the flow rate was set at 1.2 mL/min, the column temperature was 25 ℃, and the injection volume was 20 μL. Results Clozapine, clozapine N-oxide, impurity A, impurity B, impurity C, and impurity D had good linear relationships within the concentration ranges of 0.075 — 15.000, 0.076 — 15.200, 0.076 — 15.200, 0.076 — 15.200, 0.076 — 15.200, and 0.122 — 24.400 μg/mL, respectively. And their average recovery rates were 95.42%, 95.72%, 95.44%, 96.56%, 103.48%, and 104.37%, with RSD values of 0.78%, 0.92%, 0.57%, 0.65%, 1.03%, and 1.77%. Conclusions An RP-HPLC method for the detection of related substances in Clozapine Tablets is established, which is simple, accurate, and highly specific, and is suitable for quality control of Clozapine Tablets.

R927.2

四川省药物制剂及装备工程技术研究中心开放课题（ERCPEF2402）