發(fā)布時(shí)間：2018-01-13 23:13

  本文關(guān)鍵詞：高效液相色譜法測(cè)定乳酸菌素制劑中乳酸對(duì)映體的含量與比例　出處：《藥物分析雜志》2015年12期 　論文類型：期刊論文

  更多相關(guān)文章： 乳酸菌素制劑 手性固定相 乳酸對(duì)映異構(gòu)體 乳酸對(duì)映體比值 紫外檢測(cè)器 L-乳酸 D-乳酸 工藝穩(wěn)定性評(píng)價(jià)

【摘要】：目的:建立HPLC法對(duì)乳酸菌素制劑中L-乳酸和D-乳酸對(duì)映體進(jìn)行拆分,并測(cè)定兩者在乳酸菌素制劑中的含量與比例,運(yùn)用L-乳酸和D-乳酸比值對(duì)搜集到的樣本進(jìn)行可能的工藝穩(wěn)定性評(píng)價(jià)。方法:采用手性柱Chirex 3126(D青霉胺)-Phenomenex(250 mm×4.6 mm,5μm)色譜柱,以2 mmol·L~(-1)硫酸銅溶液-異丙醇(95∶5)為流動(dòng)相,流速1.0 m L·min~(-1),紫外檢測(cè)波長(zhǎng)254 nm,柱溫為30℃。結(jié)果:L-乳酸與D-乳酸質(zhì)量濃度在0.10~1.04 mg·m L~(-1)范圍內(nèi)均呈良好線性(r=0.999 9);平均回收率(n=9)分別為97.5%和98.3%;檢測(cè)限分別為0.094 4和0.124 6μg·m L~(-1);供試品溶液在48 h內(nèi)穩(wěn)定性良好;總體樣本L-乳酸和D-乳酸比值在0.93~1.68之間。結(jié)論:該方法簡(jiǎn)單快捷,適合于乳酸菌素制劑中乳酸對(duì)映體的含量測(cè)定研究,用L-乳酸和D-乳酸比值經(jīng)統(tǒng)計(jì)可以觀察樣本間離散程度,能反映出各廠間工藝穩(wěn)定性水平。
[Abstract]:Objective: to establish a HPLC method for the separation of L-lactic acid and D-lactic acid enantiomers in lactic acid preparation and to determine their content and proportion in lactic acid preparation. The possible process stability of the collected samples was evaluated by using the ratio of L- lactic acid and D- lactic acid. Methods: the chiral column Chirex 3126 D penicillamine Phenomenexe (L- lactic acid / D- lactic acid) was used to evaluate the process stability of the collected samples. 250 mm 脳 4.6 mm. A 5 渭 m column with a mobile phase of 2 mmol 路L ~ (-1) copper sulfate solution-isopropanol (95: 5) at a flow rate of 1.0 mL 路min ~ (-1). UV detection wavelength was 254 nm. The column temperature was 30 鈩，

本文編號(hào)：1420973