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机构地区:[1]山东新华制药股份有限公司,山东淄博255005
出 处:《齐鲁药事》2009年第4期212-214,共3页qilu pharmaceutical affairs
摘 要:目的建立一种硫酸奈替米星注射液旋光度测定方法,用于生产质量监控。方法在20℃下用长度为1dm的旋光管测水校零,以标准品溶液为对照计算供试品溶液的含量。结果RSD=0.07%(n=6),平均回收率为100.0%,Y=0.03524+0.14456 X,在44~56mg·mL-1溶液范围内,旋光度对浓度有良好的线性关系,r=0.99991。结论本方法简便,重复性好,准确度高,线性范围可靠,因而适于硫酸奈替米星注射液的含量测定。OBJECTIVE To establish a method of polarimetric analysis for determining the content of Netilmicin Sulfate Injection. This method was using in monitoring the quality of production. METHODS Setting a zero standard by determining the water using the polarization tube (length= 1dm) at 20℃ ,and calculated the contents of the solution. RESULTS The average recovery was 100% with theRSD = 0.07 % ( n =5)and the recovery equation was Y =0. 03524+0. 14456 X with r = 0. 99991. The optical rotation has a good linear relation with the concentration between 44-56mg · mL^-1. CONCLUSION The method was convenient,repeatable,accurate and reliable. It was therefore suitable for the quantified determination of the contents of Netilmicin Sulfate Injection.
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