中国基层医药
中國基層醫藥
중국기층의약
CHINESE JOURNAL OF PRIMARY MEDICINE AND PHARMACY
2012年
22期
3373-3374
,共2页
复方苯甲酸碘酊%反相高效液相色谱法%苯甲酸%水杨酸
複方苯甲痠碘酊%反相高效液相色譜法%苯甲痠%水楊痠
복방분갑산전정%반상고효액상색보법%분갑산%수양산
Compound Benzoic acid tincture%RP-HPLC%Benzoic acid%Salicylic acid
目的 建立同时测定复方苯甲酸碘酊中苯甲酸和水杨酸含量的反相高效液相色谱法.方法 色谱柱:ODSC18色谱柱(4.6mm×150mm,5μm);流动相:甲醇:水=60:40(pH 3.2);柱温:30℃;检测波长:242 nm;流速:0.9 ml/min.结果 苯甲酸和水杨酸的线性范围分别为30～120 mg/L(R2=0.9995)、15～60 mg/L(R2=0.9988),回收率分别为99.2％(RSD=0.95％)、99.1％(RSD=1.36％),日内RSD分别为1.57％、1.57％(n=5),日间RSD分别为1.43％、1.59％(n=5),与酸碱滴定法测定结果差异无统计学意义(P＞0.05).结论 反相高效液相色谱法适用于复方苯甲酸碘酊的含量测定,方法简便、灵敏,测定结果准确,符合制剂质量控制要求.
目的 建立同時測定複方苯甲痠碘酊中苯甲痠和水楊痠含量的反相高效液相色譜法.方法 色譜柱:ODSC18色譜柱(4.6mm×150mm,5μm);流動相:甲醇:水=60:40(pH 3.2);柱溫:30℃;檢測波長:242 nm;流速:0.9 ml/min.結果 苯甲痠和水楊痠的線性範圍分彆為30～120 mg/L(R2=0.9995)、15～60 mg/L(R2=0.9988),迴收率分彆為99.2％(RSD=0.95％)、99.1％(RSD=1.36％),日內RSD分彆為1.57％、1.57％(n=5),日間RSD分彆為1.43％、1.59％(n=5),與痠堿滴定法測定結果差異無統計學意義(P＞0.05).結論 反相高效液相色譜法適用于複方苯甲痠碘酊的含量測定,方法簡便、靈敏,測定結果準確,符閤製劑質量控製要求.
목적 건립동시측정복방분갑산전정중분갑산화수양산함량적반상고효액상색보법.방법 색보주:ODSC18색보주(4.6mm×150mm,5μm);류동상:갑순:수=60:40(pH 3.2);주온:30℃;검측파장:242 nm;류속:0.9 ml/min.결과 분갑산화수양산적선성범위분별위30～120 mg/L(R2=0.9995)、15～60 mg/L(R2=0.9988),회수솔분별위99.2％(RSD=0.95％)、99.1％(RSD=1.36％),일내RSD분별위1.57％、1.57％(n=5),일간RSD분별위1.43％、1.59％(n=5),여산감적정법측정결과차이무통계학의의(P＞0.05).결론 반상고효액상색보법괄용우복방분갑산전정적함량측정,방법간편、령민,측정결과준학,부합제제질량공제요구.
Objective To estabilish a RP-HPLC method for simultaneous determination of benzoic acid and salicylic acid in Compound Benzoic acid tincture.Methods ODSC18 chromatographic column made from Dalian Yilite(4.6mm × 150mm,5μm);mobile phase:methanol: water=60|: 40(pH adjust to 3.2);column temperature:30℃;detection wavelength:242nm;fiow rate:0.9ml/min.Results Ranges of linear of benzoic aci and salicylic acid were 30～120mg/L(R2=0.9995)and 15～60mg/L(R2=0.9988).The average recovery rate was 99.2％(RSD=0.95％)and 99.1％(RSD=1.36％).The RSDs of intra-day were 1.57％ and 1.57％(n=5).The BSDs of interday were 1.43％ and 1.59％(n=5).With t test,difference between Acid-base titration and RP-HPLC was not significant(P＞0.05).Conclusion The metold is simple,accurate and sensitive and can be used for the quality control of Compound Benzoic acid tincture.
