中国药事
中國藥事
중국약사
CHINESE PHARMACEUTICAL AFFAIRS
2014年
10期
1137-1139
,共3页
王继森%朱蓉%张亿%张姮婕
王繼森%硃蓉%張億%張姮婕
왕계삼%주용%장억%장항첩
苯甲酸水杨酸软膏%苯甲酸%水杨酸%含量测定%反相高效液相色谱%医院制剂标准修订
苯甲痠水楊痠軟膏%苯甲痠%水楊痠%含量測定%反相高效液相色譜%醫院製劑標準脩訂
분갑산수양산연고%분갑산%수양산%함량측정%반상고효액상색보%의원제제표준수정
benzoic acid and salicylic acid ointment%benzoic acid%salicylic acid%content determination%RP-HPLC%quality standard revision for the hospital preparation
目的：采用 RP-HPLC 法同时测定苯甲酸水杨酸软膏中苯甲酸和水杨酸的含量。方法采用 Kromasil C18色谱柱,以甲醇-水-冰醋酸(50∶50∶1)为流动相,检测波长：270 nm,流速：1.0 mL·min-1,柱温：30℃。结果苯甲酸、水杨酸分别在122.2~1221.6μg·mL-1、59.8~598.0μg·mL-1范围内具有良好的线性关系(r=0.9998)；回收率分别为99.2%、99.6%,RSD 分别为0.6%、0.4%。结论本法经方法学验证可用于苯甲酸水杨酸软膏中主要成分的含量测定,可作为该医院制剂质量标准修订的依据。
目的：採用 RP-HPLC 法同時測定苯甲痠水楊痠軟膏中苯甲痠和水楊痠的含量。方法採用 Kromasil C18色譜柱,以甲醇-水-冰醋痠(50∶50∶1)為流動相,檢測波長：270 nm,流速：1.0 mL·min-1,柱溫：30℃。結果苯甲痠、水楊痠分彆在122.2~1221.6μg·mL-1、59.8~598.0μg·mL-1範圍內具有良好的線性關繫(r=0.9998)；迴收率分彆為99.2%、99.6%,RSD 分彆為0.6%、0.4%。結論本法經方法學驗證可用于苯甲痠水楊痠軟膏中主要成分的含量測定,可作為該醫院製劑質量標準脩訂的依據。
목적：채용 RP-HPLC 법동시측정분갑산수양산연고중분갑산화수양산적함량。방법채용 Kromasil C18색보주,이갑순-수-빙작산(50∶50∶1)위류동상,검측파장：270 nm,류속：1.0 mL·min-1,주온：30℃。결과분갑산、수양산분별재122.2~1221.6μg·mL-1、59.8~598.0μg·mL-1범위내구유량호적선성관계(r=0.9998)；회수솔분별위99.2%、99.6%,RSD 분별위0.6%、0.4%。결론본법경방법학험증가용우분갑산수양산연고중주요성분적함량측정,가작위해의원제제질량표준수정적의거。
Objective To establish a method for content determination of benzoic acid and salicylic acid in benzoic acid and salicylic acid ointment by RP-HPLC.Methods The Kromasil C18 column was adopted. The mobile phase consisted of methanol-water-acetic acid (50∶50∶1).The detection wavelength was set at 270 nm.The flow rate was 1.0 mL · min-1 .The column temperature was 30℃.Results The linear ranges of benzoic acid and salicylic acid were 122.2-1221.6 μg · mL-1 and 59.8-598.0 μg · mL-1 (r =0.9998).The average recoveries were 99.2% (RSD = 0.6%)and 99.6% (RSD = 0.4%).Conclusion The method can be used for content determination of the main ingredients in benzoic acid and salicylic acid ointment, and can be used as the basis of quality standard revision for the hospital preparation.
