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目的建立HPLC法同时测定复方克林霉素膜中克林霉素磷酸酯、地塞米松磷酸钠、盐酸达克罗宁的含量。方法采用Diamonsil C18(150 mm×4.6mm,5μm)色谱柱,流动相:乙腈(A)-0.2%磷酸水溶液(B),梯度洗脱,检测波长:230 nm,流速:1.0 ml·min-1,柱温:25℃。结果克林霉素磷酸酯、地塞米松磷酸钠、盐酸达克罗宁分别在0.30~3.00 mg·ml-1(r=0.9997)、1.30~13.00μg·ml-1(r=0.9998)和16.00~160.00μg·ml-1(r=0.9999)范围内与峰面积线性关系良好;平均加样回收率分别为98.45%、98.89%和99.22%,RSD分别为0.83%、1.27%和0.67%(n=9)。结论本方法结果准确,专属性强,可用于复方克林霉素膜中克林霉素磷酸酯、地塞米松磷酸钠、盐酸达克罗宁的含量测定。
OBJECTIVE To establish a HPLC method for the simultaneous determination of clindamycin phosphate, dexamethasone sodium phosphate and dacronine hydrochloride in compound clindamycin membranes. Methods Diamonsil C18 column (150 mm × 4.6 mm, 5 μm) was used. The mobile phase consisted of acetonitrile (A) -0.2% phosphoric acid (B) and gradient elution. The detection wavelength was at 230 nm and the flow rate was 1.0 ml · min -1 Column temperature: 25 ° C. Results Clindamycin phosphate, dexamethasone sodium phosphate and dacronine hydrochloride were significantly higher than those of the control group at 0.30-3.00 mg · ml -1 (r = 0.9997), 1.30-13.00 μg · ml -1 (r = 0.9998) and 16.00 The average recovery was 98.45%, 98.89% and 99.22%, respectively, and the RSDs were 0.83%, 1.27% and 0.67%, respectively, for n = 160.00μg · ml- = 9). Conclusion The method is accurate and specific, and can be used for the determination of clindamycin phosphate, dexamethasone sodium phosphate and dicalronine in compound clindamycin membrane.