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* Standard solutions were prepared from Hydrochlorothiazide and Losartan potassium supplied as a reagent for laboratory use. HPLCDATA'SHEET 口廿儿夕>力中么·匕下口夕口口于了沙下锭(米国薬局方記載条件)Losartan potassium and Hydrochlorothiazide tablets (The United States Pharmacopeia) D111229A 2 System suitabilityrequirement Result Resolution(1,2) 22 13.8 ≤2.0% 0.02% 1 2 3 4 5 6 7 )Uniformity of dosage units: Standard solution* (0.014 mg/mL Hydrochlorothiazide, 0.06 mg/mL Losartan potassium) mAU 2 250) 200 1 System suitability Result 150 requirement 100 Resolution (1,2) ≥2 13.7 Relative standard deviation ≤2.0% 0.02% of the peak area(1,2) 0 D111101A T 0 1 2 3 4 5 6 7 min Column : YMC-Pack C: (10 um, 12 nm) 250X4.6mml.D. Eluent : phosphate buffer (pH 2.5)*-/acetonitrile (60/40) *Dissolve 1.36 g of KH2PO4 in 1000 mL of water, and adjust pH 2.5 with H3PO4 Flow rate :2.3 mL/min Temperature :35℃ Detection : UV at 230 nm Injection : 20 uL (The United States Pharmacopeia 34th) 氯沙坦钾氢氯噻嗪片溶出度及含量均匀度检查色谱条件(USP) 仪 器:液相色谱仪检测器:UV (230nm)色谱柱:YMC-Pack C8色谱柱(内径:4.6mm 长度:250mm 粒径:10μm)流动相:乙腈-磷酸盐缓冲溶液* 2:3 *缓冲溶液:将1.36克磷酸二氢钾溶于900ml水中,并用磷酸调pH至2.5,再加水稀释至1000ml柱 温: 35℃流 速:2.3ml/min 进样量:20μl
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