| 李茜,刘英.HPLC法检测醋酸奥曲肽注射剂中5种抑菌剂[J].中国药事,2017,(1):60-68 |
| HPLC法检测醋酸奥曲肽注射剂中5种抑菌剂 |
| HPLC Determination of Five Antibacterial Agents in Octreotide Acetate Injection |
| 投稿时间：2016-04-09 |
| DOI：10.16153/j.1002-7777.2017.01.012 |
| 中文关键词: 醋酸奥曲肽 醋酸奥曲肽注射液 注射用醋酸奥曲肽 抑菌剂 苯酚 苯甲醇 三氯叔丁醇 对羟基苯甲酸甲酯 对羟基苯甲酸丙酯 |
| 英文关键词: octreotide acetate octreotide acetate injection octreotide acetate for injection antibacterial agents phenol benzyl alcohol chlorobutanol methyl p-hydroxybenzoate propyl p-hydroxybenzoate |
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| 中文摘要: |
| 目的：检测醋酸奥曲肽注射剂中是否添加苯酚、苯甲醇、三氯叔丁醇、对羟基苯甲酸甲酯及对羟基苯甲酸丙酯5种抑菌剂。方法：采用C18（L）（4.6 mm×250 mm，5 μm）色谱柱，流动相A为水，流动相B为甲醇，梯度洗脱，流速为1.0 mL·min-1，柱温30℃，检测波长为220 nm及256 nm。结果：苯酚、苯甲醇、三氯叔丁醇、对羟基苯甲酸甲酯及对羟基苯甲酸丙酯各峰均分离良好；苯酚在1.29~258.60 μg·mL-1范围内线性关系良好（r=1.000），平均回收率为100.0%（n=9）；苯甲醇在2.72~544.20 μg·mL-1范围内线性关系良好（r=0.9997），平均回收率为100.3%（n=9）；三氯叔丁醇在9.95~1990.00 μg·mL-1范围内线性关系良好（r=1.000），平均回收率为100.9%（n=9）；对羟基苯甲酸甲酯在0.27~53.80 μg·mL-1范围内线性关系良好（r=1.000），平均回收率为100.5%（n=9）；对羟基苯甲酸丙酯在0.26~52.00 μg·mL-1范围内线性关系良好（r=1.000），平均回收率为99.4%（n=9）；91批醋酸奥曲肽注射剂中均未检出5种抑菌剂。结论：该方法准确、灵敏、简便，可用于醋酸奥曲肽注射剂中苯酚、苯甲醇、三氯叔丁醇、对羟基苯甲酸甲酯及对羟基苯甲酸丙酯5种抑菌剂的检查。 |
| 英文摘要: |
| Objective: To detect whether the octreotide acetate injection was added with the five antibacterial agents of phenol, benzyl alcohol, chlorobutanol, methyl p-hydroxybenzoate and propyl p-hydroxybenzoate. Methods: An Agela Venusuil ASB C18 (L) (4.6 mm×250 mm, 5 μm) column was adopted. The mobile phase A was water and the mobile phase B was methanol, the flow rate was 1.0 mL·min-1, the column temperature was 30℃, and the detection wavelength was 220 nm and 256 nm. Results: The five kinds of antibacterial agents were well separated. The linear range of phoenol was 1.29~258.60 μg·mL-1, and the average recovery was 100.0%(n=9). The linear range of benzyl alcohol was 2.72~544.20 μg·mL-1, and the average recovery was 100.3%(n=9). The linear range of chlorobutanol was 9.95~1990.00 μg·mL-1, and the average recovery was 100.9%(n=9). The linear range of methyl p-hydroxybenzoate was 0.27~53.80 μg·mL-1, and the average recovery was 100.5%(n=9). The linear range of propyl p-hydroxybenzoate was 0.26~52.00 μg·mL-1, and the average recovery was 99.4% (n=9). None of the five kinds of antibacterial agents were detected in the 91 batches of octreotide acetate injection. Conclusion: The method is accurate, sensitive and simple, and can be used for determination of phenol, benzyl alcohol, chlorobutanol, methyl p-hydroxybenzoate and propyl p-hydroxybenzoate in octreotide acetate injection. |
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