Citation: MAHA Hegazy, AMIRA Kessiba, MOHAMED Abdelkawy, AHMED EMAD El Gindy. A novel liquid chromatographic method with fluorescence detection for quantitation of tadalafil and dapoxetine hydrochloride in pharmaceutical dosage form and human plasma[J]. Chinese Journal of Chromatography, ;2015, 33(7): 765-770. doi: 10.3724/SP.J.1123.2015.02063 shu

A novel liquid chromatographic method with fluorescence detection for quantitation of tadalafil and dapoxetine hydrochloride in pharmaceutical dosage form and human plasma

1.
1. Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Cairo 11562, Egypt;

Corresponding author: MAHA Hegazy,
Received Date: 10 February 2015

Tadalafil (TAD) and dapoxetine HCl (DAP) are recently co-formulated and both show native fluorescence. Therefore, a novel, accurate, specific and sensitive reversed-phase high performance liquid chromatographic method with fluorescence detection was developed and validated for their separation and quantitation in dosage form and human plasma using avanafil as an internal standard (IS). Separation was achieved using isocratic elution within 7.0 min on C₁₈ column and acetonitrile-0.15% triethylamine (40 : 60, v/v; pH 4) as a mobile phase. The flow rate was 1.0 mL/min and the detection was time-programmed at 330, 410 and 370 nm for TAD, DAP and IS, respectively, after excitation at 236 nm. The linear ranges from 0.01 to 30.00 μg/mL for each drug with the limits of detection of 4.20 and 7.20 ng/mL for TAD and DAP, respectively. The method was validated in accordance to the International Conference on Harmonization (ICH) guidelines and was successfully applied to spiked human plasma with mean recoveries of 98.17% and 98.83% for TAD and DAP respectively.
- high performance liquid chromatography (HPLC),
- fluorescence detection,
- tadalafil (TAD),
- dapoxetine HCl (DAP),
- dosage form,
- human plasma
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沈阳化工大学材料科学与工程学院沈阳 110142