【摘要】：目的:建立HPLC-RID法測(cè)定和比較不同企業(yè)生產(chǎn)的克拉霉素緩釋片中骨架輔料羥丙甲纖維素(HPMC)的含量,同時(shí)評(píng)價(jià)該輔料與釋放度之間可能存在的相關(guān)性。方法:采用TSK-Gel 3000色譜柱(300 mm×7.5 mm,10μm),以50 mmol·L~(-1)氯化鈉溶液為流動(dòng)相進(jìn)行洗脫,流速0.7 m L·min~(-1),柱溫30℃,檢測(cè)溫度30℃,進(jìn)樣量5μL。結(jié)果:本法可以有效測(cè)定HPMC且與其它峰能良好分離,溶液在24 h內(nèi)穩(wěn)定;樣品中的HPMC含量為標(biāo)示量的85%~107%。結(jié)論:本方法可以有效地測(cè)定克拉霉素緩釋片中HPMC含量,同時(shí)該輔料含量與該藥品的體外釋放存在一定的相關(guān)性。
[Abstract]:Objective: to establish a HPLC-RID method to determine and compare the content of hydroxypropylcellulose (HPMC) in clarithromycin sustained-release tablets produced by different enterprises, and to evaluate the possible correlation between the excipient and the release rate. Methods: TSK-Gel 3000 column (300 mm 脳 7.5 mm,10 渭 m),) with 50 mmol L-1 sodium chloride solution as mobile phase was used for elution. The flow rate was 0.7 mL min~ (-1), the column temperature was 30 鈩，

本文編號(hào)：2408515