肌苷氯化钠注射液中肌苷含量的两种测定方法比较

目的：比较肌苷氯化钠注射液中肌苷含量的两种测定方法.方法：分别采用高效液相色谱（HPLC）法及紫外分光光度（UV）法测定.HPLC法采用DiamonsilTM C18柱（250 mm×4.6 mm,5μm）,以甲醇-水（10∶ 90）为流动相,检测波长为248nm,流速为1.0 ml·min-1,进样量为20 μl,柱温为30℃.UV法采用水为溶剂,检测波长为248 nm.结果：HPLC法肌苷质量浓度在6.51 ～32.56 μg· ml-1范围内与峰面积线性关系良好,r=0.999 9,平均回收率为99.78％,RSD=0.24％（n=9）;UV法肌苷质量浓度在6.0～14.0 μg·ml-1范围内与吸光度线性关系良好,r =0.999 6,平均回收率为99.31％,RSD =0.25％ （n=9）.统计学结果显示两种方法测定结果差异无统计学意义（P＞0.05）.结论：UV法可以作为肌苷氯化钠注射液半成品含量的测定方法.

Determination of Inosine in Inosine and Sodium Chloride Injections Respectively by UV Spectrophotometry and HPLC

Objective：To compare UV and HPLC method for the content determination of inosine in inosine and sodium injections.Methods：The content determination of inosine was determined by HPLC and UV method,respectively.The HPLC method adopted a DiamonsilTM C18 column（250 mm × 4.6 mm,5 μm） with the mobile phase of methanol-water（10∶ 90） and the detection wavelength of 248 nm.The flow rate was 1.0 ml · min-1,the injection volume was 20μ1 and the column temperature was 30℃.The UV method adopted the detection wavelength of 248 nm with water as the solvent.Results：There was a good linearity within the range of 6.51-32.56 μg · ml-1 for inosine （r =0.999 9） by HPLC.The average recovery was 99.78 % （RSD =0.24%,n =9）.There was a good linearity within the range of 6.0-14.0 μg · ml-1 for inosine （r =0.999 6） by UV.The average recovery was 99.31% （RSD =0.25 %,n =9）.There was no significant difference between the determination results of the two methods （P 〉 0.05）.Conclusion：The UV method can be used in the content determination of inosine in half-finished products of inosine and sodium injections.