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| HPLC测定盐酸四氢唑啉滴眼液的含量及其有关物质 | |
| 引用本文： | 税庆华,韩保萍,王玉玲,张世磊,于盛茂. HPLC测定盐酸四氢唑啉滴眼液的含量及其有关物质[J]. 中国药学杂志, 2008, 43(19): 1513-1515 |
| 作者姓名： | 税庆华 韩保萍 王玉玲 张世磊 于盛茂 |
| 作者单位： | 1. 山东博士伦福瑞达制药有限公司,济南,250014 2. 山东省生物药物研究院,济南,250014 |
| 摘 要： | 目的建立HPLC测定盐酸四氢唑啉滴眼液含量的方法。方法采用Diamonsil C18(4.6mm×150mm,5μm)色谱柱;以甲醇-醋酸盐缓冲液(40:60)为流动相,检测波长为235nm。结果盐酸四氢唑啉质量浓度在9.94～497.0mg·L-1内与峰面积呈良好线性关系(r=0.9999);最低检测限为0.22ng;平均回收率为99.86%,RSD为0.23%。结论本方法灵敏度高,方法操作简便,可满足本品含量及有关物质的测定。 |
| 关 键 词： | 盐酸四氢唑啉滴眼液 含量测定 有关物质 高效液相色谱法 |
| 收稿时间： | 2007-12-18; |
Determination of Tetrahydrozoline Hydrochloride and Its Related Substances in Eye Drops By HPLC |
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| SHUI Qing-hua,HAN Bao-ping,WANG Yu-ling,ZHANG Shi-lei,YU Sheng-mao. Determination of Tetrahydrozoline Hydrochloride and Its Related Substances in Eye Drops By HPLC[J]. Chinese Pharmaceutical Journal, 2008, 43(19): 1513-1515 | |
| Authors: | SHUI Qing-hua HAN Bao-ping WANG Yu-ling ZHANG Shi-lei YU Sheng-mao |
| Affiliation: | 1. Shandong Bausch﹠Lomb Freda Pharmaceuticals Co.，Lid.，Jinan 250014，China；2. Institute of Biopharmaceuticals of Shandong Province，Jinan 250014，China |
| Abstract: | OBJECTIVE To establish a HPLC method for determining the content of tetrahydrozoline hydrochloride and its related substances in eye drops.METHODS A diamonsil C18 column(4.6 mm×150 mm,5 μm)was used with a mobile phase of methanol-acetate buffer(40∶60).The detection was carried out at 235 nm.RESULTS The determination limit was 0.22 ng.The standard curve was linear in the range of 9.94-497.0 mg·L-1(r=0.999 9).The average recovery was 99.86% and RSD was 0.23%.CONCLUSION The method established is successfully used to determine tetrahydrozoline hydrochloride and its related substances in eye drops. |
| Keywords: | tetrahydrozoline hydrochloride eye drops assay related substances HPLC |
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