【摘要】：目的建立反相HPLC法測(cè)定鹽酸倍他司汀口服液中有關(guān)物質(zhì)含量。方法采用Diamonsil C18色譜柱(150 mm×4.6 mm,5μm),流動(dòng)相:p H 4.7的醋酸銨緩沖溶液(650 m L,約含2.88 g十二烷基硫酸鈉)-乙腈(體積比為65∶35),流速:1.0 m L·min-1,進(jìn)樣量:20μL,檢測(cè)波長(zhǎng):261 nm,柱溫:40℃。結(jié)果在該色譜條件下,3批樣品中各雜質(zhì)質(zhì)量分?jǐn)?shù)分別為,雜質(zhì)A(×10-2):6.385%、6.247%、6.164%;雜質(zhì)B(×10-2):4.901%、4.916%、4.741%;雜質(zhì)C未檢測(cè)到;其他單個(gè)最大雜質(zhì)(×10-2):6.329%、5.892%、5.306%;總雜質(zhì)(×10-1):2.209%、2.119%、2.022%。結(jié)論該方法可用于鹽酸倍他司汀口服液中有關(guān)物質(zhì)的檢查。
[Abstract]:Objective to establish a reversed-phase HPLC method for the determination of related substances in betastine hydrochloride oral liquid. Methods the Diamonsil C18 column (150 mm 脳 4.6 mm,5 渭 m), mobile phase,: p H 4.7) was used as an ammonium acetate buffer solution (650ml, containing about 2.88g sodium dodecyl sulfate) -acetonitrile (65:35 by volume). Flow rate: 1.0 mL min-1, injection: 20 渭 L, detection wavelength: 261 nm, column temperature: 40 鈩，

本文編號(hào)：2342784