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HPLC测定二氟泼尼酯眼用乳剂的含量
引用本文:王金虎,郭文建. HPLC测定二氟泼尼酯眼用乳剂的含量[J]. 山东食品科技, 2012, 0(11): 428-430
作者姓名:王金虎  郭文建
作者单位:[1]山东省医药工业研究所,山东济南250101 [2]山东省化药重点室验室,山东济南250101
摘    要:建立高效液相色谱法测定二氟泼尼酯眼用乳剂中二氟泼尼酯的含量。方法采用SHIMADZU VP-ODS C18(150mm×4.6mm,5μm)色谱柱,流动相为甲醇-水(52:48),检测波长240nm,流速1.0mL/min,柱温35℃。结果二氟泼尼酯在2.034-20.34μg/mL浓度范围内与峰面积有良好的线性关系,平均回收率98.80%。结论此方法结果简便,准确,重复性好,可以用于二氟泼尼酯眼用乳剂的质量控制。

关 键 词:高效液相色谱法  二氟泼尼酯  含量测定

Determination of the Difluprednate Ophthalmic Emulsion by I-IPLC
WANG Jin-hu,GUO Wen-jian. Determination of the Difluprednate Ophthalmic Emulsion by I-IPLC[J]. , 2012, 0(11): 428-430
Authors:WANG Jin-hu  GUO Wen-jian
Affiliation:1. Shandong Institute of Pharmaceutical Industry, Jinan 250101 China, 2. Shandong Provincial Key Laboratory of Chemical Drug, Jinan 250101 China)
Abstract:Objective To establish an HPLC method for the determination of the difluprednate in difluprednate ophthalmic emulsion. Methods SHIMADZU VP-ODS C18 column (150 mm×4.6 mm, 5 μm) was adopted, the methanol-water (52:48) was used as mobile phase, the detection wavelength was 240 nm, the flow rate was 1.0 mL/ min, and the column temperature was 40 ℃. Results The linear range of difluprednate was 2.034- 20.34 μg/mL, the average recovery rate was 98.80%. Conclusion The method was simple, accurate and reproducible, can be used for quality control of difluprednate ophthalmic emulsion.
Keywords:HPLC  difluprednate  assay
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