目的 建立HPLC法測定氯氮平片中有關物質(zhì)。方法 采用Hypersil BDS色譜柱（200 mm×4.6 mm，5 mm）；流動相為1 mol/L冰醋酸-[甲醇-乙腈（1∶1）]，梯度洗脫；檢測波長為257 nm；體積流量為1.2 mL/min；柱溫為25 ℃；進樣體積為20 mL。結果 氯氮平、氯氮平N-氧化物、雜質(zhì)A、雜質(zhì)B、雜質(zhì)C、雜質(zhì)D分別在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線性關系良好，平均回收率分別為95.42%、95.72%、95.44%、96.56%、103.48%、104.37%，RSD值分別為0.78%、0.92%、0.57%、0.65%、1.03%、1.77%。結論 建立了氯氮平片中有關物質(zhì)檢查的HPLC法，簡便、準確、專屬性強，適用于氯氮平片的質(zhì)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

四川省藥物制劑及裝備工程技術研究中心開放課題（ERCPEF2402）