摘要
目的:建立测定硫酸西索米星氯化钠注射液(SSJ)中西索米星含量的方法。方法:采用旋光度-标准曲线法(旋光法)测定SSJ中西索米星的含量。以钠光谱的D线(589.3nm)测定旋光度,测定管长度为2dm,测定温度为20℃,并与标准方法——微生物检定法测定结果进行比较。结果:西索米星检测浓度线性范围为0.4～2.0mg·mL-1(r=0.9999),平均回收率为97.6%,RSD=0.80%(n=6);旋光法与微生物检定法含量测定结果一致,RSD分别为0～0.07%、0.57%～1.2%。结论:旋光法测定SSJ中西索米星含量的方法简便、准确,且重现性优于微生物检定法。
OBJECTIVE： To establish the method for content determination of sisomicin in Sisomicin sulfate and sodium chlo- ride injection （SSJ）. METHODS： The optical rotation-standard curve method （polarimetry） was adopted for the content determina- tion of sisomicin in SSJ. The D line of sodium spectrum （589.3 rim） was adopted to determine the optical rotations with the length of determination tube of 2 dm and determination temperature of 20 ＇E, and it was compared with standard method microbial method. RESULTS： The linear range of sisomicin was 0.4-2.0 mg.mL -1（r=0.999 9） with an average recovery of 97.6% （RSD= 0.80%, n=6）; results of polarimetry （RSD=01--0.07%） was in line with that of microbial method （RSD=0.57%-1.2%）. CON- CLUSION： The method is simple and accurate, and the reproducibility of it is better than microbial method.
出处
《中国药房》
CAS
CSCD
2012年第41期3906-3907,共2页
China Pharmacy
关键词
硫酸西索米星氯化钠注射液
旋光法
微生物检定法
含量测定
Sisomicin sulfate and sodium chloride injection
Polarimetry
Microbial method
Content determination
