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目的:建立滴强灵胶囊中3组分的HPLC测定方法。方法:以COSMOSIL C_(18)(250 mm×4.6 mm,5μm)为色谱柱,以醋酸铵溶液[0.25 mol·L~(-1)醋酸铵溶液-0.05 mol·L~(-1)EDTA-2Na溶液-三乙胺(100:10:1),用醋酸调pH至7.5]-乙腈(88:12)为流动相测定甲硝唑和土霉素的含量,流速1 ml·min~(-1),检测波长280 nn,柱温30℃;以甲醇-水(60:40)为流动相测定醋酸泼尼松的含量,流速1 ml·min~(-1),检测波长240 nm,柱温30℃。结果:建立的HPLC法能排除辅料对主药中3组分的干扰,甲硝唑、土霉素、醋酸泼尼松的含量测定的线性范围分别为0.04～0.80 mg·ml~(-1)(r=0.999 9),0.02～0.40 mg·ml~(-1)(r=0.999 9)和0.02～0.40 mg·ml~(-1)(r=0.999 9);平均回收率分别为99.94%(RSD=0.07%)、99.85%(RSD=0.09%)、98.16(RSD=1.58%)(n=6)。结论:本法操作简便可靠,可用于滴强灵胶囊的质量控制。
Objective: To establish a method for the determination of 3 components in Droplet Capsules by HPLC. METHODS: COSMOSIL C_ (18) (250 mm × 4.6 mm, 5 μm) was used as the chromatographic column. Ammonium acetate solution [0.25 mol·L -1 ammonium acetate solution -0.05 mol·L -1 EDTA- The content of metronidazole and oxytetracycline was measured with a mobile phase of 2Na solution-triethylamine (100: 10: 1), adjusted to pH 7.5 with acetic acid-acetonitrile (88:12) 1). The detection wavelength was 280 nn and the column temperature was 30 ℃. The content of prednisone acetate was determined by the mobile phase of methanol-water (60:40), the flow rate was 1 ml · min -1 and the detection wavelength was set at 240 nm. Temperature 30 ℃. Results: The established HPLC method could eliminate the interference of the excipients on the three components of the main drug. The linear range of metronidazole, oxytetracycline and prednisone acetate was 0.04-0.80 mg · ml -1, (r = 0.999 9), 0.02-0.40 mg · ml -1 (r = 0.999 9) and 0.02-0.40 mg · ml -1 (r = 0.999 9) .The average recoveries were 99.94% (RSD = 0.07%), 99.85% (RSD = 0.09%), 98.16 (RSD = 1.58%) (n = 6). Conclusion: This method is simple and reliable, and can be used for quality control of Droplet Capsules.