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作 者:雷晓雪[1] 陶元景[1] 陈文芝[1] 王丽楠[1]
机构地区:[1]扬子江药业集团南京海陵药业有限公司,南京210049
出 处:《中国药房》2013年第37期3540-3541,共2页China Pharmacy
摘 要:目的:建立快速测定甲磺酸罗哌卡因注射液生产中中间产品含量的方法。方法:采用紫外分光光度法。以0.9%氯化钠溶液为溶剂,检测波长为262 nm,同时与高效液相色谱法含量测定结果比较。结果:甲磺酸罗哌卡因检测质量浓度线性范围为37~740μg/m(lr=0.999 8),平均回收率为99.80%(RSD=0.4%,n=9)。2种方法含量测定结果一致。结论:建立的方法简便、准确、快速,可用于甲磺酸罗哌卡因注射液大生产过程中中间产品的质量控制。OBJECTIVE: To establish a rapid method for the content determination of intermediate product of Ropivacaine me- sylate injection. METHODS: UV spectrophotometry was adopted. 0.9 % sodium chloride solution was taken as solvent and the de- tection wavelength was set at 262 nm. Result of the method was compared with that of HPLC method. RESULTS: The linear range of ropivacaine mesylate were 37-740 pg/ml (r----0.999 8) with an average recovery of 99.80% (RSD=0.4%, n=9). Results of content determination by 2 kinds of methods were the same to each other. CONCLUSIONS: Established method is simple, accurate and rapid, and it can be used for quality control of intermediate product of Ropivacaine mesylate injection.
关 键 词:紫外分光光度法 甲磺酸罗哌卡因注射液 含量测定
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