HPLC法测定注射用萘普生钠的含量及有关物质
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王丽君1，王东凯1，黎 玲1,赵 鹏1，张印策2
(1. 沈阳药科大学 药学院，辽宁 沈阳 110016；2. 沈阳沃森药物研究所，辽宁 沈阳 110016)
摘 要：目的 建立HPLC测定注射用萘普生钠的含量及有关物质的方法。方法 用十八烷基键合硅胶为填充剂，乙腈-水-冰醋酸(体积比49: 50: 1)为流动相，检测波长为262 nm。结果 萘普生钠在0.09～1.2 mg·mL-1质量浓度范围内线性关系良好，相关系数r=0.999 8。平均回收率为99.7%，精密度及稳定性均较好。结论 本方法稳定，重现性好，结果准确，可同时用于测定含量及有关物质检查。
关键词: 药剂学；含量测定；高效液相色谱法；萘普生钠
中图分类号: R944.1 文献标识码: A
Determination of naproxen sodium for injection with HPLC
WANG Li-jun1 , WANG Dong-kai 1, LI Ling1, ZHAO Peng1, ZHANG Yin-ce2
(1.School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016,China; 2.Watson Pharmaceutical Institute of Shenyang, Shenyang 110016,China)
Abstract: Objective To establish methods for the determination of naproxen sodium for injection and its related substances. Methods The mobile phase consisted of acetonitrile-water-glacial acetic acid(49:50:1). Detection wavelength was set at 262 mn. Results There was good linear correlation in the range of 0.09–1.20 mg·mL-1(r=0.999 8). The average recovery of naproxen sodium for injection was 99.7%(n=6). Conclusions The method is rapid, simple, and accurate.
Key words: pharmaceutics; determination; HPLC; naproxen sodium
王丽君1，王东凯1，黎 玲1,赵 鹏1，张印策2
(1. 沈阳药科大学 药学院，辽宁 沈阳 110016；2. 沈阳沃森药物研究所，辽宁 沈阳 110016)
摘 要：目的 建立HPLC测定注射用萘普生钠的含量及有关物质的方法。方法 用十八烷基键合硅胶为填充剂，乙腈-水-冰醋酸(体积比49: 50: 1)为流动相，检测波长为262 nm。结果 萘普生钠在0.09～1.2 mg·mL-1质量浓度范围内线性关系良好，相关系数r=0.999 8。平均回收率为99.7%，精密度及稳定性均较好。结论 本方法稳定，重现性好，结果准确，可同时用于测定含量及有关物质检查。
关键词: 药剂学；含量测定；高效液相色谱法；萘普生钠
中图分类号: R944.1 文献标识码: A
Determination of naproxen sodium for injection with HPLC
WANG Li-jun1 , WANG Dong-kai 1, LI Ling1, ZHAO Peng1, ZHANG Yin-ce2
(1.School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016,China; 2.Watson Pharmaceutical Institute of Shenyang, Shenyang 110016,China)
Abstract: Objective To establish methods for the determination of naproxen sodium for injection and its related substances. Methods The mobile phase consisted of acetonitrile-water-glacial acetic acid(49:50:1). Detection wavelength was set at 262 mn. Results There was good linear correlation in the range of 0.09–1.20 mg·mL-1(r=0.999 8). The average recovery of naproxen sodium for injection was 99.7%(n=6). Conclusions The method is rapid, simple, and accurate.
Key words: pharmaceutics; determination; HPLC; naproxen sodium
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