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| 气相色谱法测定药用辅料聚乳酸中丙交酯残留量 | |
| 引用本文： | 刘智慧,尹霞,王燕清,徐朋,何玉华,陈斌. 气相色谱法测定药用辅料聚乳酸中丙交酯残留量[J]. 海峡药学, 2020, 32(6): 50-51. DOI: 10.3969/j.issn.1006-3765.2020.06.017 |
| 作者姓名： | 刘智慧 尹霞 王燕清 徐朋 何玉华 陈斌 |
| 作者单位： | 丽珠医药集团珠海市丽珠微球科技有限公司,广东珠海, 519090,丽珠医药集团珠海市丽珠微球科技有限公司,广东珠海, 519090,丽珠医药集团珠海市丽珠微球科技有限公司,广东珠海, 519090,丽珠医药集团珠海市丽珠微球科技有限公司,广东珠海, 519090,丽珠医药集团珠海市丽珠微球科技有限公司,广东珠海, 519090,丽珠医药集团珠海市丽珠微球科技有限公司,广东珠海, 519090 |
| 基金项目： | "广东省引进创新创业团队"项目;"珠海市引进创新创业团队"项目;国家"重大新药创制"项目 |
| 摘 要： | 目的建立聚乳酸中丙交酯残留量的测定方法。方法采用毛细管气相色谱法,色谱柱为Agilent HP-5(30.0m×0.32mm,0.25μm),柱温150℃;分流比10∶1;检测器为氢火焰离子化检测器(FID),检测器温度为250℃,进样口温度为200℃。结果丙交酯在90.1~675.9μg·mL^-1范围内与峰面积线性关系良好(r=0.9999),平均回收率为96.5%,RSD为3.3%(n=9),定量限为2.9μg·mL^-1。结论该方法专属性强,重复性好,灵敏度高,结果可靠,适用于聚乳酸中丙交酯的残留检查。 |
| 关 键 词： | 聚乳酸 气相色谱法 丙交酯 |
Determination of Residual Lactide in the Excipient Poly ( lactic acid) by GC |
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| LIU Zhi-hui,YIN Xia,WANG Yan-qing,XU Peng,HE Yu-hua,CHEN Bin. Determination of Residual Lactide in the Excipient Poly ( lactic acid) by GC[J]. Strait Pharmaceutical Journal, 2020, 32(6): 50-51. DOI: 10.3969/j.issn.1006-3765.2020.06.017 | |
| Authors: | LIU Zhi-hui YIN Xia WANG Yan-qing XU Peng HE Yu-hua CHEN Bin |
| Affiliation: | (Zhuhai Livzon Microsphere Technology CO.,LTD.,Zhuhai 519090,China) |
| Abstract: | OBJECTIVE To establish a method to determine the residual solvent lactide in poly(lactic acid).METHODS The GC was carried out with Agilent HP-5 capillary column(30.0m×0.32mm,0.25μm).The column temperature was 150℃,Split ratio was 10∶1,the temperature of FID detector was 250℃,The inlet temperature was 200℃.RESULTS The standard curves of lactide was linear within the ranges of 90.1-675.9μg·mL^-1(r=0.9999).The average recovery of lactide was 96.5%,the RSD for replications were 3.3%(n=9).The limit of quantitation was 2.9μg·mL^-1.CONCLUSION The method is specific,reproducible,high sensitive and reliable,which can be used todetermine the lactide residue in poly(lactic acid). |
| Keywords: | Poly(lactic acid) GC Lactide |
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