| 梅芊,刘英.HPLC法测定醋酸奥曲肽注射剂中醋酸的含量[J].中国药品标准,2017,18(4):271-274 |
| HPLC法测定醋酸奥曲肽注射剂中醋酸的含量 |
| HPLC Determination of Acetic Acid in Octreotide Acetate Injection and For injection |
| 投稿时间：2017-05-10 修订日期：2017-08-01 |
| DOI： |
| 中文关键词: 醋酸奥曲肽 醋酸奥曲肽注射剂 醋酸 |
| 英文关键词: Octreotide acetate Octreotide acetate injection acetic acid |
| 基金项目: |
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| 摘要点击次数: 617 |
| 全文下载次数: 143 |
| 中文摘要: |
| 目的：建立HPLC法测定醋酸奥曲肽注射剂中的醋酸含量。方法：采用Agilent ZORBAX SB-Aq(4.6mm×250mm, 5μm)色谱柱,流动相A为0.01mol/L磷酸氢二铵溶液(用磷酸调节pH值至2.5),流动相B为甲醇,梯度洗脱,流速为0.6 mL.min-1,UV检测器,检测波长210 nm,柱温27℃。结果：醋酸浓度在2.08μg.mL-1 ~38.94 μg.mL-1范围内线性关系良好(r=0.9999),平均回收率为99.3%(n=9)；70批醋酸奥曲肽注射液的醋酸含量为10.6%~15.4%；21批注射用醋酸奥曲肽中7批未检出醋酸,14批含量为1.7%~4.2%；原研企业诺华公司的1批醋酸奥曲肽注射液醋酸含量为12.5%,与国内企业生产的醋酸奥曲肽注射液中醋酸含量基本相同。结论：该方法操作简便、准确度高、灵敏度好,可用于醋酸奥曲肽注射剂中醋酸的含量测定与质量控制。 |
| 英文摘要: |
| Objective: To establish an HPLC method for content of acetic acid in the octreotide acetate injection and for injection.Methods: An Agilent ZORBAX SB-Aq(4.6mm×250mm, 5μm)column was adopted and UV was detected.The detection wavelength was set at 210 nm.The mobile phase A was 0.01mol/L (NH4)2HPO4(pH 2.5)and mobile phase B was methanol, using gradient elution at a flow rate of 0.6 mL.min-1.The column temperature was set at 27 ℃.Results: The linear rang of acetic acid was 2.08μg.mL-1 ~38.94 μg.mL-1(r=0.9999), the average recovery was 99.3%(n=9). The content range of acetic acid was 10.6%~15.4 % in 70 batches of octreotide acetate injection, the content range of 14 batched of octreotide acetic acid was 1.7%~4.2% and 7 batches was not detected in 21 batches of octreotide acetate for injection.12.5% acetic acid was detected in original octreotide acetate injection from Novartis which was similar to domestic octreotide acetate injection. Conclusion: The method is simple and easy to operate with high accuracy and sensitivity and which can be use for determination of acetic acid and quality control in Octreotide acetate injection and for injection. |
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