Validated Stability Indicating HPTLC and UV-Spectrophotometric Techniques for the Determination of Avanafil

Abstract

Aims: To develop methods with complete validation according to ICH guidelines and to be applied for the determination of avanafil in pure form and in pharmaceutical formulation in the presence of its degradation products.
 Study Design: High performance thin layer chromatography (HPTLC) and different spectrophotometric methods (dual wavelength, first derivative, first derivative of ratio spectra and ratio difference are developed for simultaneous determination of avanafil in laboratory-prepared mixtures of avanafil with its degradation products and in pharmaceutical formulation.
 Place and Duration of Study: Sample: Department of Analytical Chemistry, Faculty of Pharmacy (Girls), Al-Azhar University, Cairo, Egypt, between May 2019 and September 2019.
 Methodology: Two techniques have been developed for the determination of avanafil in the presence of its degradation products. The first was HPTLC where separation was performed on silica gel 60 F254 plates, with chloroform: toluene: methanol: conc. ammonia (6:5:3:0.1, by volume) as a developing system and UV detection at 230 nm. The second one was UV- spectrophotometry which included dual wavelength between 267 and 292 nm, first derivative determination of the drug at 261 nm, first derivative of ratio of peak amplitudes at 275.6, 305.4 and 329 nm and the ratio difference with the amplitude difference between (266 and 250 nm).
 Results: HPTLC method was applied over the concentration range of 0.5-5. μg/spot, while spectrophotometric methods were linear over the concentration range 5-50 μg/mL for avanafil.
 Conclusion: Novel, simple and accurate method for the determination of avanafil in laboratory-prepared mixtures of avanafil with its degradation products and in pharmaceutical formulation.

Environmentally benign first derivative synchronous spectrofluorimetry for the analysis of two binary mixtures containing duloxetine with avanafil or tadalafil in spiked plasma samples

“…It was found that our method is advantageous in various points. Regarding sensitivity, the developed approaches are more sensitive than the published methods [18–20, 22, 38, 39, 41, 46–49]. Furthermore, our method is the simplest and greenest approach for the analysis of the examined drugs in plasma samples.…”

“…It has lower adverse effects and faster onset than other PDE5 inhibitors [26,27]. Several analytical methods have been reported for the estimation of AVA, such as chromatographic methods [28][29][30][31][32][33][34][35][36][37][38][39], spectrophotometry [38,39], and spectrofluorimetry [40][41][42].…”

An Eco-Friendly Solid-State Electrode Modified With ZnO Nanoparticles Decorated With MWCNT as an Electrochemical Sensor for the Determination of Avanafil in Pure Form, Dosage Form and Human Plasma

“…The best peak appeared at pH 6 and the scan rate was 100 mV s −1 . pH effect.-The effect of pH on the electrochemical analysis of AVA was investigated using 0.04 M BR buffers with different pH values (2)(3)(4)(5)(6)(7)(8)(9). It was found that the pH value of a solution affects the electrochemical behavior such as peak current and potential of the oxidation of AVA.…”

“…2 It is readily soluble in 0.1 M hydrochloric acid, non-water soluble, slightly soluble in ethanol and sparingly soluble in methanol. 2 Different studies for the estimation of AVA alone or in a mixture with other drugs were reported such as UV-vis spectrophotometry, [3][4][5][6] HPLC, 7-10 HPTLC 11 and fluorimetry. 12 Electroanalytical methods have many advantages compared to other traditional methods such as high sensitivity, low time-consuming, low detection limit, especially when using modified electrodes, relatively inexpensive and simple operations.…”

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

“…Recently, AVA was co-formulated with DAP to treat impotence and premature ejaculation. Several techniques were reported for the estimation of AVA in drug products including spectrophotometry [5,6], HPLC [7][8][9], LC-MS/MS [10] and voltammetry [11]. Different studies were developed for the determination of DAP alone or in a combination with other drugs including UV-Vis spectrophotometry [12][13][14][15], HPLC [16][17][18][19][20][21][22], capillary electrophoresis [23,24], screen printed electrode [25] and potentiometric ion-selective electrodes [26].The analytical techniques for determination of AVA and DAP in binary mixtures were reported including spectrophotometry [27,28], HPLC [29,30], HPTLC [31] and fluorimetry [32].…”