本文選題：高效液相色譜法 + 愈酚維林片�。� 參考：《中國藥房》2017年12期

【摘要】：目的:建立愈酚維林片溶出度的測定方法,并比較不同廠家制劑的差異。方法:采用漿法進行溶出,以水為溶出介質(zhì),體積為1 000 m L,轉(zhuǎn)速為75 r/min,取樣時間為45 min;采用高效液相色譜法測定制劑中枸櫞酸噴托維林和愈創(chuàng)甘油醚的溶出度:色譜柱為CAPCELL PAK C_(18)MGⅡS-5,流動相為乙腈-磷酸三乙胺緩沖溶液(p H 2.6±0.05)(33∶67,V/V),流速為1.0 m L/min,檢測波長為215 nm(枸櫞酸噴托維林)、275 nm(愈創(chuàng)甘油醚),柱溫為35℃,進樣量為20μL。結(jié)果:枸櫞酸噴托維林、愈創(chuàng)甘油醚檢測質(zhì)量濃度線性范圍分別為5.091 6~50.915 5μg/m L(r=0.999 9)、29.999 5~299.995 2μg/m L(r=0.999 9);精密度、穩(wěn)定性、重復(fù)性試驗的RSD2.0%;加樣回收率分別為97.90%~100.68%(RSD=0.95%,n=9)、97.09%~101.85%(RSD=1.32%,n=9)。6個廠家樣品中枸櫞酸噴托維林的平均累積溶出度分別為12%、98%、66%、97%、91%、32%(n=3),愈創(chuàng)甘油醚分別為8%、95%、68%、90%、93%、18%(n=3)。結(jié)論:該方法簡便、準確、靈敏度高、專屬性強,適于愈酚維林片的溶出度測定;不同廠家樣品及同一廠家同批次樣品間的溶出度均存在較大差異。
[Abstract]:Objective: to establish a method for determination of dissolution of guaipheneverine tablets and compare the differences of different preparations. Methods: the slurry method was used for dissolution, and water was used as the dissolution medium. The volume is 1 000 mL, the rotational speed is 75 r / min and the sampling time is 45 min. The dissolution of citrate and guaiacol ethers in the preparation is determined by HPLC. The chromatographic column is CAPCELL PAK Cn18MG-II S-5, and the mobile phase is acetonitrile-triphosphate. Ethylamine buffer solution (H 2.6 鹵0.05) 33: 67 V / V, flow rate 1.0 mL / min, detection wavelength 215 nm (guaiacylglycerol ethers) 275 nm (guaiacol ether), column temperature 35 鈩，

本文編號：2035542