腺苷钴胺片溶出度试验方法的建立

目的:建立腺苷钴胺片溶出度测定方法,并对4个企业的12批样品进行溶出度测定。方法:采用小杯法,以水200 ml为溶出介质,转速75 r/min,溶出取样点为30 min;采用高效液相色谱法检测含量,色谱柱为YMC C18,流动相为0.05 mol/L磷酸二氢钾溶液(pH 3.2)-乙腈(85∶15),检测波长为260 nm,进样量为50μl。结果:腺苷钴胺检测质量浓度线性范围为0.257 5¹.545 0μg/ml(r=0.999 5),平均回收率为99.2%(n=3)。不同取样时间点6片间及3批样品间溶出量的RSD均不超过9.3%(n=6);12批样品30 min时溶出量数据约为40%1.545 0μg/ml(r=0.999 5),平均回收率为99.2%(n=3)。不同取样时间点6片间及3批样品间溶出量的RSD均不超过9.3%(n=6);12批样品30 min时溶出量数据约为40%⁹7%。结论:各厂家样品溶出度结果差异较大,本方法具有区别腺苷钴胺片不同处方和生产工艺的能力,能有效控制该制剂的质量。

Establishment of the Method for Dissolution Test of Cobamamide Tablets

OBJECTIVE： To establish the method for dissolution test of Cobamamide tablets, and to determine the dissolution of 12 batches of samples from 4 factories. METHODS： Small glass method was used with 200 ml water as medium at the rotation speed of 75 r/min. The dissolution time was 30 min. HPLC method was adopted, and the detection wavelength was set at 260 nm. The determination was performed on YMC C18 column with mobile phase consisted of 0.05 mol/L potassium dihydrogen phosphate solution （pH 3.2）-acetonitrile （85 ： 15）. The sample size was 50 μl. RESULTS： The linear range of cobamamide was 0.257 5- 1.545 0 μg/ml （r=0.999 5） with an average recovery of 99.2% （n=3）. RSD of dissolution curves of 6 tablets or 3 batches of samples were all lower than 9.3% （n=6） at the different time points. The dissolution of 12 batches of samples were 40%-97% within 30 min. CONCLUSIONS： The dissolution of samples from different manufacturers are different greatly. The method can identify different formulation and production process, and can be applied to control the quality of Cobamamide tablets.