中国药师
中國藥師
중국약사
CHINA PHARMACIST
2015年
5期
867-869
,共3页
高效液相色谱-二极管阵列检测器-蒸发光散射检测器联用%复方吐温软膏%硫酸新霉素%盐酸达克罗宁%含量测定
高效液相色譜-二極管陣列檢測器-蒸髮光散射檢測器聯用%複方吐溫軟膏%硫痠新黴素%鹽痠達剋囉寧%含量測定
고효액상색보-이겁관진렬검측기-증발광산사검측기련용%복방토온연고%류산신매소%염산체극라저%함량측정
HPLC-DAD-ELSD%Compound Twain ointments%Neomycin sulfate%Dyclonine hydrochloride%Content determination
目的：：建立同时测定复方吐温软膏中硫酸新霉素与盐酸达克罗宁含量的HPLC-DAD-ELSD法。方法：采用 Agilent ZOR BAXSB-C18色谱柱(250 mm ×4.6 mm,5μm),以含0.1 mol·L-1三氟乙酸的水溶液、乙腈为流动相,梯度洗脱,流速为1.0 ml·min-1,DAD的检测波长为282 nm,ELSD的漂移管温度为50℃,雾化温度为60℃,载气流速为1.6 L·min-1,柱温为35℃。结果：硫酸新霉素检测浓度的线性范围为141.540~323.520μg·ml-1(r=0.9996),平均回收率为98.87%,RSD=0.95%(n=9)；盐酸达克罗宁检测浓的线性范围为28.000~64.000μg·ml-1(r=0.9996),平均回收率为99.57%,RSD=1.10%(n=9)。结论：该方法结果准确、灵敏度高、重复性好,在同一色谱条件下实现了复方吐温软膏中全部有效成分的含量测定,为其质量控制提供了依据。
目的：：建立同時測定複方吐溫軟膏中硫痠新黴素與鹽痠達剋囉寧含量的HPLC-DAD-ELSD法。方法：採用 Agilent ZOR BAXSB-C18色譜柱(250 mm ×4.6 mm,5μm),以含0.1 mol·L-1三氟乙痠的水溶液、乙腈為流動相,梯度洗脫,流速為1.0 ml·min-1,DAD的檢測波長為282 nm,ELSD的漂移管溫度為50℃,霧化溫度為60℃,載氣流速為1.6 L·min-1,柱溫為35℃。結果：硫痠新黴素檢測濃度的線性範圍為141.540~323.520μg·ml-1(r=0.9996),平均迴收率為98.87%,RSD=0.95%(n=9)；鹽痠達剋囉寧檢測濃的線性範圍為28.000~64.000μg·ml-1(r=0.9996),平均迴收率為99.57%,RSD=1.10%(n=9)。結論：該方法結果準確、靈敏度高、重複性好,在同一色譜條件下實現瞭複方吐溫軟膏中全部有效成分的含量測定,為其質量控製提供瞭依據。
목적：：건립동시측정복방토온연고중류산신매소여염산체극라저함량적HPLC-DAD-ELSD법。방법：채용 Agilent ZOR BAXSB-C18색보주(250 mm ×4.6 mm,5μm),이함0.1 mol·L-1삼불을산적수용액、을정위류동상,제도세탈,류속위1.0 ml·min-1,DAD적검측파장위282 nm,ELSD적표이관온도위50℃,무화온도위60℃,재기류속위1.6 L·min-1,주온위35℃。결과：류산신매소검측농도적선성범위위141.540~323.520μg·ml-1(r=0.9996),평균회수솔위98.87%,RSD=0.95%(n=9)；염산체극라저검측농적선성범위위28.000~64.000μg·ml-1(r=0.9996),평균회수솔위99.57%,RSD=1.10%(n=9)。결론：해방법결과준학、령민도고、중복성호,재동일색보조건하실현료복방토온연고중전부유효성분적함량측정,위기질량공제제공료의거。
Objective:To establish an HPLC-DAD-ELSD method for the simultaneous determination of neomycin sulfate and hy-drochloric dyclonine in compound Twaln ointments. Methods:The assay was performed on an Agilent ZOR BAXSB-C18 column(250 mm × 4. 6 mm, 5μm) with acetonitrile-water as the mobile phase with gradient elution at a flow rate of 1. 0 ml·min-1 . The detection wavelength of DAD was 282 nm. The evaporator temperature of ELSD was set at 50℃ and the nebulizer temperature was set at 60℃with the gas flow rate of 1. 6 L·min-1 . The column temperature was kept at 35℃. Results:The linear range of neomycin sulfate was 141. 54-323. 52 μg·mL-1(r=0. 999 6) with the average recovery of 98. 87%(RSD=0. 95%, n=9). The linear range of hydro-chloric dyclonine was 28. 00-64. 00 μg·mL-1(r=0. 999 6) with the average recovery of 99. 57%(RSD=1. 10%, n=9). Conclu-sion:The method is accurate, sensitive and reproducible, and under the same chromatographic conditions, the determination of all the active ingredients in compound Twaln ointments is achieved, which provides basis for the quality control.
