本文選題：泮托拉唑鈉腸溶膠囊　切入點：HPLC法　出處：《安徽醫(yī)藥》2016年04期 　論文類型：期刊論文

【摘要】：目的建立泮托拉唑鈉腸溶膠囊含量及有關(guān)物質(zhì)的質(zhì)量控制方法,并對上市品進(jìn)行穩(wěn)定性研究。方法以Agilent C18柱(250 nm×4.6 nm,5μm)為色譜柱,流動相為磷酸二氫鈉緩沖(1.20 g的磷酸二氫鈉溶解于1 000 m L的水中,用磷酸調(diào)節(jié)p H至7.0)—乙腈(68∶32),流速1 m L·min-1,檢測波長288 nm,對膠囊進(jìn)行有關(guān)物質(zhì)及含量的檢測;采用加速試驗,在溫度(40±2)℃、相對濕度(75±5)%的條件下放置6個月,考察其穩(wěn)定性。結(jié)果泮托拉唑鈉在(1.0~10.0)×10-3g·L-1濃度范圍內(nèi)線性關(guān)系良好,檢測限為0.20 ng,定量限為0.60 ng,平均加樣回收率為100.57%(RSD=0.41%),測定樣品平均含量為100.67%,有關(guān)物質(zhì)均小于0.2%。穩(wěn)定性試驗結(jié)果含量在99.70%~101.16%,有關(guān)物質(zhì)小于0.2%。結(jié)論該方法快速,簡單,穩(wěn)定,重現(xiàn)性好,可作為泮托拉唑鈉腸溶膠囊的含量及有關(guān)物質(zhì)的檢測方法。穩(wěn)定性檢測結(jié)果符合要求。
[Abstract]:Objective to establish a method for quality control of pam Tora sodium enteric-coated capsules and to study its stability. Methods the Agilent C18 column (250nm 脳 4.6 nm) was used as chromatographic column. The mobile phase consisted of sodium dihydrogen phosphate buffer 1.20 g sodium dihydrogen phosphate dissolved in water of 1 000 mL, adjusted with phosphoric acid to 7.0% -acetonitrile 68: 32, flow rate 1 mL 路min -1, detection wavelength 288 nm. The stability of pam Tora sodium was investigated at 40 鹵2 鈩，

本文編號：1592301