反相高效液相色谱法同时测定制剂中柠檬酸西地那非和盐酸地西汀的含量

Shivanand Yadav, N. Sharma
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引用次数: 0

摘要

建立了一种简便、准确、精密的反相高效液相色谱(RP-HPLC)同时测定枸橼酸西地那非(SIL)和盐酸地西汀(DAP)复方剂型的方法,并进行了验证。反相高效液相色谱法采用Shimadzu - 1800,软件版本- UV Prob 2.33, BDS hypersil C18色谱柱,缓冲液pH 4.0与ACN以40:60的比例为流动相。采用波长为229 nm的紫外可见检测器:岛津SPD-20AT二极管阵列检测器。在西地那非50 ~ 150ppm和达泊西汀30 ~ 90ppm的浓度范围内,色谱法均呈线性关系。HPLC法测定SIL的回收率为99.3% ~ 100.5%,DAP的回收率为99.1% ~ 100.4%。两种方法均可用于药物制剂中药物的常规分析。分析结果经统计学验证。关键词:线性,验证,高效液相色谱,西地那非,地泊西汀。
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DEVELOPMENT OF REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS ESTIMATION OF SILDENAFIL CITRATE AND DEPOXETINE HYDROCHLORIDE IN PHARMACEUTICAL FORMULATION
Simple, accurate and precise reversed-phase high-performance liquid chromatographic (RP-HPLC) methods for simultaneous estimation of sildenafil citrate (SIL) and depoxetine hydrochloride (DAP) in combined tablet dosage form have been developed and validated. The RP-HPLC method uses a Shimadzu – 1800, Software Version – UV Prob 2.33 with BDS hypersil C18 column and mixture of Buffer pH 4.0 and ACN in the ratio of 40:60 as the mobile phase. The detection was carried out using a UV–Visible Detector: Shimadzu SPD–20AT diode array detector set at 229 nm. Linearity of chromatographic method was found in the concentration range of 50 - 150 ppm for Sildenafil and 30 - 90 ppm for Dapoxetine respectively. % recovery for SIL was found to be 99.3 – 100.5 %, while for DAP it was found to be in range of 99.1 – 100.4 % in HPLC methods respectively. Both methods may be used for routine analysis of the drugs in a pharmaceutical formulation. Results of analysis were validated statistically. KEYWORDS: Linearity, Validation, HPLC, Sildenafil, Depoxetine.
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