抗肿瘤药卡培他滨原料药的质量控制及稳定性考察

目的建立抗肿瘤药卡培他滨原料药的质量控制方法，并考察其稳定性。方法采用高效液相色谱法测定卡培他滨原料药含量和有关物质，并考察其在加速试验和长期试验条件下的稳定性。结果建立了卡培他滨原料药的质量控制方法，包括性状、鉴别、比旋度（＋96．00_＋100．0。）、有关物质（≤1．0％）、水分（≤0-3％）、炽灼残渣（≤0．1％）、重金属（≤20mg，kg）和含量测定（98．0％～102．0％），样品检测检测结果在规定的限度内，并分别在加速试验（40±2）℃，相对湿度75％±5％]和长期试验（30±2）℃，相对湿度60％±5％]条件下进行了3个月的稳定性试验，稳定性考察期内各项指标未见明显变化。结论所建立的卡培他滨原料药质量控制方法重复性好、专属性强，结果准确可靠，稳定性检测结果在规定的限度内，卡培他滨原料药稳定性良好。

Quality control and stability study of anticancer drug capecitabine

Objective To establish the method of the quality control of anticaneer drug eapeeitabine and observe its stability. Methods Capeeitabine bulk drug content and related substances were determined by high performance liquid chromatography,and the stability under the condition of the accelerated test and long-term test was investigated. Re- suits The method of the quality control of eapecitabine was established,which included character, identification,optical rotation （＋96.0~ to ＋ 100.0~）,related substance （ ~〈 1.0%）,water determination （ ~〈 0.3% ）,residue on ignition （ ~〈 0.1%）,heavy metals （~〈20 mg/kg） and content determination （98.0%-102.0%）,the test results were all within defined margin.Mean- while,the stability was observed in accelerated testing（40~2）~C,RH 75%_＋5%] and long-term testing（30_＋2）~C,RH 60%_＋ 5%] for 3 months,no obvious changes were observed in each index of stability test. Conclusion The established quality control method of eapecitabine is recurrent and specific,the results are accurate and reliable,the test results of stability are within defined margin,eapeeitabine has good stability.