摘要
目的 建立复方甲硝唑片中主药甲硝唑和法莫替丁的含量测定方法。方法 采用高效液相色谱法 ,色谱柱 :SpherisorbC1 8(1 50mm× 4 .6mm ,5μm)不锈钢柱 ,流动相 :pH 3 .0 ,0 .0 5mol·L- 1 磷酸盐缓冲液 乙腈 甲醇 (88∶1 0∶2 ) ,检测波长 2 65nm ,内标法定量。结果 在优化的色谱条件下 ,甲硝唑、法莫替丁和内标氢氯噻嗪间均能完全分离 ,片剂辅料不干扰测定 ,甲硝唑、法莫替丁的线性范围分别为 1 0 0～ 50 0 μg·mL- 1 和 5～ 2 5μg·mL- 1 ,回收率分别为 99.79%和 1 0 0 .6 % ,RSD <1 .5 %。结论 该法专属性强 ,操作方便 ,结果准确 。
OBJECTIVE: A high performance liquid chromatographic assay was established for the determination of metronidazole and famotidine in compound metronidazole tablet. METHODS: Reversed-phase chromatographic separation was carried out on a Spherisorb C18 column (150 mm × 4.6 mm, 5 μm) equilibrated with an eluent mixture conseituted by 0.05 mol·L-1 phosphate buffer(pH 3.0)-acetonitril-methanol (88:10:2). The ultraviolet detection was at 265 nm. Hydrochlorothiazide was used as an internal standard. RESULTS: Complete separation was achieved among metronidazole, famotidine and Hydrochlorothiazide under optimum conditions. No interference from tablet excipients was found. The standard curve was linear over the range of 100 to 500 μgμmL-1 for metronidazole and 5 to 25 μg·mL-1 for famotidine, respectively. The recoveries were 99.79% for metronidazole and 100.6% for famotidine with RSD less than 1.5%. CONCLUSIONS: The proposed method is selective, simple, accurate and reproducible.
出处
《中国药学杂志》
EI
CAS
CSCD
北大核心
2002年第12期935-938,共4页
Chinese Pharmaceutical Journal
