含碘复方苯甲酸醇溶液的质量标准研究

摘要

Objective To establish a quality standard for compound benzoic acid with iodine alcoholic solution. Methods Camphor was identified by TLC. Benzoic acid and salicylic acid were determined by HPLC. The HPLC system consisted of Agilent Eclipse XDB-C18 (250 mm × 4. 6 mm, 5 μm) and methanol-0. 05% phosphate acid solution(50: 50). The flow rate was 1.0 ml ·min-1, detection wavelength set at 283 nm, and the column temperature was 30℃. Results Camphor was identified by TLC. The linear range of benzoic acid was 144-500 μg ·ml-1 (r = 1. 000, n = 6). The recovery of low, middle and high groups was 101. 58%, 100. 00%, 99.63% while RSD was 0. 25%, 0. 31%, 0. 14%. The linear range of salicylic acid was 72-250 μg · ml-1 (r = 0.999, re =6). The recovery of low, middle and high groups was 102. 60%, 101. 34%, 101. 69% and RSD was 0.36%, 0. 33%, 0.20%. Conclusion This method is simple, accurate and reproducible for quality control of compound benzoic acid with iodine alcoholic solution.%目的 提高含碘复方苯甲酸醇溶液的质量标准.方法 采用TLC对含碘复方苯甲酸醇溶液中樟脑进行了鉴别；采用HPLC法测定该制剂中苯甲酸与水杨酸的含量,色谱柱为Agilent Eclipse XDB-C18(4.6 mm x250 mm,5μm)；流动相为甲醇-0.05％磷酸溶液(50:50)；检测波长为283nm；流速为1.0 ml ·min-1；柱温30℃.结果 TLC法可鉴别出该制剂中樟脑.苯甲酸在144～500μg ·ml-1范围内浓度与峰面积呈良好的线性关系(r =1.000,n=6)；低、中、高3个浓度的平均回收率分别为101.58％,100.00％,99.63％；RSD分别为0.25％,0.31％,0.14％；水杨酸在72 ～250 μg·m1-1范围内浓度与峰面积线性关系良好(r =0.999,n=6)；低、中、高3个浓度的平均回收率分别为102.60％,101.34％,101.69％；RSD分别为0.36％,0.33％,0.20％.结论 该方法简便,准确,重复性好,可用于含碘复方苯甲酸醇溶液质量控制.