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

Main Article Content

Manal K. Darwish
Marwa M. Soliman
Sawsan A. Abdel-Razeq

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.

Keywords:
Avanafil, HPTLC, dual wavelength, first derivative, first derivative of ratio spectra, ratio difference.

Article Details

How to Cite
Darwish, M. K., Soliman, M. M., & Abdel-Razeq, S. A. (2019). Validated Stability Indicating HPTLC and UV-Spectrophotometric Techniques for the Determination of Avanafil. Asian Journal of Chemical Sciences, 6(4), 1-16. https://doi.org/10.9734/ajocs/2019/v6i419005
Section
Original Research Article

References

Kedia GT, Uckert S, Assadi-Pour F, Kuczyk MA, Albrecht K. Avanafil for the treatment of erectile dysfunction: Initial data and clinical key properties. Ther. Adv. Urol. 2013;5(1):35-41.

Martindale. The complete drug reference. 38th Edition, The Pharmaceutical Press, Londone; 2014.

Kashyap R, Srinivasa U, Badodaria K. Development and validation of RP-HPLC method for simultaneous estimation of avanafil and dapoxetine HCL in tablet dosage form. WJPPS. 2014;3(7):1697-1719.

Bhumik B, Kashyap R, Buddhadev S. Stability indicating analytical method development and validation for estimation of avanafil in pharmaceutical dosage form. Int. J. Pharm. Drug Anal. 2015;3(6):181-194.

Hegazy M, Kessiba A, Abdelkawy M, El-Gindy AE. RP-HPLC with time programmed fluorescence detection for quantitation of avanafil and dapoxetine hydrochloride: Application to pharmaceutical dosage form and bological fluid. J Liq. Chromatogr. Relat. Technol. 2015;38(18):1660-1665.

Fahmy UA, Aljaeid BM. Stability indicating HPLC method for analysis of avanafil using diode array detector. IJAPBC. 2016;5(1):59-64.

Kumar N, Sangeetha D, Kalyanraman L, Sainath K. Stability-indicating HPLC method for simultaneous determination of degradation products and process-related impurities of avanafil in avanafil tablets. Acta Chromatogr. 2018;30(3):158-163.

Chaudhari HH, Sen DJ, Patel CN. Development and validation of HPTLC method for simultaneous estimation of avanafil and dapoxetine HCL in tablet dosage form. WJPPS. 2015;4(5):1566-1575.

Shah DA, Vegad KL, Patel ED, Prajapati HK, Patel RN, Patel YK. Analytical method validation for estimation of avanafil and dapoxetine hydrochloride tablet dosage form by HPTLC method. Pharm. Biol. Eval. 2017;4(3):171-179.

Can NO. Development of validated and stability-indicating LC-DAD and LC-MS/MS methods for determination of avanafil in pharmaceutical preparations and identification of a novel degradation product by LCMS-IT-TOF. Molecules. 2018;23(7):1771.

Savaliya SD, Chaudhary AB, Rathod BG, Dobariya TD, Mohan S. Development and validation of UV- spectrophotometric method for estimation of avanafil in tablet dosage form. Inventi Rapid: Pharm. Analysis & Quality Assurance; 2013.

Kashyap R, Srinivasa U. Development and validation of new colorimeteric method for the estimation of avanafil in bulk and dosage form. IJPT. 2013;5(3):5811-5826.

Kashyap R, Srinivasa U, Badodaria K. First order derivative and dual wavelength spectrophotometry methods development and validation for simultaneous estimation of avanafil and dapoxetine hydrochloride in bulk and dosage. IJPT. 2014;6(1):6418-6438.

Patel MN, Kothari CS. Multivariate approaches for simultaneous determination of avanafil and dapoxetine by UV chemometrics and HPLC-QbD in binary mixtures and pharmaceutical product. J. AOAC Int. 2016;99(3):649-663.

Tailor PM, Patel VV, Mishra AD, Shah SA, Shah DR. Spectrofluorimetric method for the estimation of avanafil in bulk and their tablet dosage form. RRJODFDP. 2016;3(3):1-5.

Soliman MM, Darwish MK, Abdel-Razeq SAM. Validated stability indicating HPTLC, UHPLC and UV-spectrophotometric techniques for the determination of bepotastine besilate in presence of its oxidative degradate. Asian Journal of Applied Chemistry Research. 2019;3(1):1-14.

Scheinmann F. An introduction to spectroscopic methods for the identification of organic compounds. Pergamon Press. 2013;2.

Abdel-Razeq SA, Abdel-Salam KM, Fouad MM, Mohamed TF. Stability indicating spectrophotometric methods for the determination of pramipexole dihydrochloride. WJPPS. 2015;3(12):1444-1457.

ICH Q2 (R1). Validation of analytical procedures: Methodology; 2005.