HPLC法测定注射用乙酰谷酰胺的含量
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文章编号：(2005)05–0302–04,HPLC法测定注射用乙酰谷酰胺的含量
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纪 标1，王东凯1，薛梅妍1，徐 飒2
(1.沈阳药科大学 药学院， 沈阳 110016；2.沈阳沃森药物研究所， 沈阳 110016)
摘要 目的 建立HPLC法测定注射用乙酰谷酰胺的含量。方法 使用Diamonsil C18柱(250 mm×4.6 mm,5 μm )，流动相为0.05 mol·L-1磷酸二氢钾(pH 3.0)–甲醇(体积比为 75∶25)，流速1.0 mL·min-1，检测波长为210 nm。结果 乙酰谷酰胺在50～250 mg·L-1内质量浓度与峰面积呈良好线性关系，r＝0.999 9，平均回收率为100.2 %。结论 该方法可用于注射用乙酰谷酰胺的含量测定。
关键词：药剂学；高效液相色谱法；乙酰谷酰胺；含量测定
中图分类号：R94 文献标识码： A
Assay of aceglutamide for injection by an HPLC method
JI Biao1，WANG Dong–kai1，XUE Mei–yan1，XU Sa2
(1.School of Pharmacy, Shenyang Pharmaceutical University，Shenyang 110016,China；2. Watson Pharmaceutical Institute of Shenyang，Shenyang 110016, China)
Abstract: Objective To establish an HPLC method for the assay of aceglutamide for injection. Methods The Diamonsil C18 column(250 mm×4.6 mm,5 μm ) was used，the mobile phase was 0.05 mol·L-1phosphate buffer (pH 3.0)–methanol(75∶25)，the flow rate was 1.0 mL·min-1 ，the detection wavelength was at 210 nm. Results The linearity range for aceglutamide was 50～250 mg·L-1 with a regression coefficient of 0.999 9 and an average recovery of 100.2 %. Conclution This method is simple ,rapid and accurate ,and can be used to test the potency of aceglutamide for injection.
Key words：pharmaceutics；HPLC；aceglutamide；assay
纪 标1，王东凯1，薛梅妍1，徐 飒2
(1.沈阳药科大学 药学院， 沈阳 110016；2.沈阳沃森药物研究所， 沈阳 110016)
摘要 目的 建立HPLC法测定注射用乙酰谷酰胺的含量。方法 使用Diamonsil C18柱(250 mm×4.6 mm,5 μm )，流动相为0.05 mol·L-1磷酸二氢钾(pH 3.0)–甲醇(体积比为 75∶25)，流速1.0 mL·min-1，检测波长为210 nm。结果 乙酰谷酰胺在50～250 mg·L-1内质量浓度与峰面积呈良好线性关系，r＝0.999 9，平均回收率为100.2 %。结论 该方法可用于注射用乙酰谷酰胺的含量测定。
关键词：药剂学；高效液相色谱法；乙酰谷酰胺；含量测定
中图分类号：R94 文献标识码： A
Assay of aceglutamide for injection by an HPLC method
JI Biao1，WANG Dong–kai1，XUE Mei–yan1，XU Sa2
(1.School of Pharmacy, Shenyang Pharmaceutical University，Shenyang 110016,China；2. Watson Pharmaceutical Institute of Shenyang，Shenyang 110016, China)
Abstract: Objective To establish an HPLC method for the assay of aceglutamide for injection. Methods The Diamonsil C18 column(250 mm×4.6 mm,5 μm ) was used，the mobile phase was 0.05 mol·L-1phosphate buffer (pH 3.0)–methanol(75∶25)，the flow rate was 1.0 mL·min-1 ，the detection wavelength was at 210 nm. Results The linearity range for aceglutamide was 50～250 mg·L-1 with a regression coefficient of 0.999 9 and an average recovery of 100.2 %. Conclution This method is simple ,rapid and accurate ,and can be used to test the potency of aceglutamide for injection.
Key words：pharmaceutics；HPLC；aceglutamide；assay
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