三磷酸腺苷二钠注射液中辅料苯甲醇的含量检测

目的 建立HPLC法测定三磷酸腺苷二钠注射液中辅料苯甲醇的含量.方法 采用JADE-PAKODS-AQ（4.6 mm×250 mm,5μm）色谱柱;流动相：0.2 mol·L^-1磷酸盐缓冲液-甲醇（95 ∶ 5）,流速：0.8 mL·min^-1,检测波长：218 nm,进样量：10μL,柱温：35℃.结果 苯甲醇浓度在0.02083～0.52095 mg·mL^-1范围内线性关系良好（r=0.9999,n=7）,平均回收率为99.99％（n=9）.结论 该方法操作简便,经方法学验证可用于测定三磷酸腺苷二钠注射液中辅料苯甲醇的含量.

Content Determination of Adjuvant Benzyl Alcohol in Adenosine Disodium Triphosphate Injection

Objective To establish a determination method of the adjuvant material benzyl alcohol in adenosine disodium triphosphate injection by HPLC. Methods The JADE-PAK ODS-AQ column （4. 6 mm × 250 mm, 5μm） was used; the mobile phase was 0.2 mol ·L^-1 phosphate buffer solution-methanol （95 ： 5） with a flow rate at 0.8 mL · min^-1 , the detection wavelength was 218 nm at a temperature of 35 ℃. The injection volume was 10 μL. Results The linear range of benzyl alcohol was within 0.02083-0. 52095 mg · mL^-1 （r = 0. 9999, n=7）. The average recovery was 99.99% （n=9）. Conclusion The method is simple, which can be used for the determination of the adjuvant material benzyl alcohol in adenosine disodium triphosphate injection according to methodology validation.