氯沙坦钾氢氯噻嗪片中溶出度，含量均匀度检测方案(液相色谱柱)

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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