Validated Capillary Zone Electrophoretic Determination of Avanafil and Dapoxetine Hydrochloride in their Pure form and Pharmaceutical Preparation

التفاصيل البيبلوغرافية
العنوان: Validated Capillary Zone Electrophoretic Determination of Avanafil and Dapoxetine Hydrochloride in their Pure form and Pharmaceutical Preparation
المؤلفون: Samir Morshedy, Gamal A. Omran, Mohamed B. Ali, Wael Talaat, Hassan A.M. Hendawy
المصدر: Journal of Pharmaceutical Research International. :446-459
بيانات النشر: Sciencedomain International, 2021.
سنة النشر: 2021
مصطلحات موضوعية: Electrophoresis, Chromatography, Capillary action, Chemistry, medicine, Avanafil, Dapoxetine hydrochloride, medicine.drug
الوصف: Aims: In this study, a simple, green, and rapid capillary zone electrophoresis (CZE) method coupled with a diode array detector (DAD) was applied for the analysis of avanafil (AVA) and dapoxetine hydrochloride (DAP) as a binary mixture using vardenafil (VAR) as an internal standard (IS) in pure form and pharmaceutical formulation. Methodology: The separation was done using fused silica capillary (58.5 cm total length, 50 cm effective length, and 50 μm internal diameter) and the running background electrolyte (BGE) was 100 mM acetate buffer at pH 3.6. During the separation process, the applied voltage was 30 KV, while the temperature was 25 °C. The sample injection was applied at a pressure of 50 mbar for 10 s, and detection was carried out at 210 nm for DAP and 248 nm for AVA and VAR. Results: Analysis of the tested drugs and the internal standard was carried out in less than 6.5 min, where the migration times were 4.29, 4.90, and 6.02 min for IS, DAP and AVA respectively. The proposed method showed linearity in the concentration range 5-80 and 5-70 μg/mL with correlation coefficients 0.9996 and 0.9999 for AVA and DAP respectively. The limit of detection (LOD) was 0.523 and 0.531 for AVA and DAP respectively, while the limit of quantification (LOQ) was 1.585 and 1.608 in respective order. The Peak purity and identity in the proposed method were validated by DAD. Conclusion: The proposed CZE method was validated according to ICH guidelines and applied successfully for the estimation of AVA and DAP in their combined pharmaceutical preparation.
تدمد: 2456-9119
DOI: 10.9734/jpri/2021/v33i46b32960
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_________::9844da18fdf2d90e890ee928dfdfaa6a
https://doi.org/10.9734/jpri/2021/v33i46b32960
Rights: OPEN
رقم الانضمام: edsair.doi...........9844da18fdf2d90e890ee928dfdfaa6a
قاعدة البيانات: OpenAIRE
الوصف
تدمد:24569119
DOI:10.9734/jpri/2021/v33i46b32960