ANALYTICAL METHOD DEVELOPMENT, VALIDATION AND STABILITY INDICATING STUDIES OF AVANAFIL BY USING RP-HPLC TECHNIQUE

Main Article Content

J. Sunayana
L. Siva Sanker Reddy
R. Nageswara Rao
S. Muneer
N. Madana Gopal
N. Yella Subbaiah
Shaik Ruksar
K. Maheshwari
C. Madhsudhana Chetty

Keywords

Avanafil, Methanol, HPLC, Degradation studies, ICH Guidelines

Abstract

Objective: The project was aimed at developing an analytical method to quantify Avanafil drug either alone or in tablet formulation, including stability studies by practicing RP-HPLC technique.


Methods: The RP-HPLC technique was carried to work out an analytical method and inspecting consistency of the method by performing the different validation parameters. The degradation studies were performed under different physical and chemical conditions following the ICH guidelines. The column used was Inertsil ODS Column C18 (4.6×250mm)5µm.


Findings: In the course of stream lining the analytical method, we have clinched on to use the mobile phase with the combination of Methanol: 0.1% OPA (75:25v/v). The drug was detected at 246 nm in UV. The retention time was at 3.14 min and the linearity range of was from 0.5 µg/ml to 10µg/ml with the Regression coefficient calculated to be (R2) 0.9978. The corresponding recognition limits (LOD and LOQ) was 0.02µg/ml and 0.08µg/ml respectively. Precision studies were carried out and the RSD values were found to be less than two. The degradation studies were successfully conducted.


Novelty: The significant advantages were reduction of retention time almost one minute less, the lower limit in linearity being at least 10 times less and the mobile phase used was quite cheaper than the reported methods. The other part was that, the usability of the method to quantify even though the drug was degraded nearly to 10 % in presence of the unknown degradants. The method is also sensitive, reproducible, quick and economical.

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References

1. https://pubchem.ncbi.nlm.nih.gov/compound/Avanafil.
2. Bhatt bhumik, Raval Kashyap, Sheetal Buddhadev, Stability indicating analytical method development and validation for the estimation of avanafil in pharmaceutical dosage form, international journal of pharmaceutics and drug analysis, 2015, 3(6), 181-194. https:// www.s emanticscholar.org/paper/STABILITY-INDICATING-ANALYTICAL-METHOD-DEVELOPM ENT-Bhumik-Kashyap/a57ec2afeb1743006f59c27fc454906d67b3545b#citing-papers
3. P. Pavani, T. Raja Rajeswari, G. Ramana Reddy, Development and validation of stability indicating HPLC method for estimation of related substances in avanafil, Indo American Journal of Pharmaceutical Research, 2017, 7(4), 8318-8329. https://zenodo.org/record/2526065
4. Nitin kumar, D. Sangeetha, L. Kalyanraman, K.Sainath, Stability-indicating HPLC method for simultaneous determination of degradation products and process related impurities of avanafil in avanafil tablets, Acta Chromatographica, 2018, 30 (3), 158-163. https://doi.org/ 10.1556/ 1326. 2017.00116
5. M. V. Jadhav, A. Akash, V. Munipalli, R. M. Singh, S. Nayak, B. Vaidhun, Development and validation of reverse phase high performance liquid chromatography method for quantitative estimation of Avanafil in tablet dosage form, Journal of Pharma Innovation, 2020, 1(1), 29-37.
6. Mital Patel, Charmy Kothari, Comprehensive stability-indicating method development of Avanafil Phosphodiesterase type 5 inhibitor using advanced Quality-by-Design approach, Journal of Analytical science and Technology, 2020 , 11(29), 1-14. https://doi.org/10.1186/s40543-020-00228-4
7. J.Peris-Vicente, J.Esteve-Romero, S. Carda-Broch. Validation of analytical methods based on chromatographic techniques: An overview. Analytical separation science .2015 Nov 25:1757-1808. https:// demarcheiso 17025.com/ document/ Validation%20of% 20Analytical%20 Methods %20Based%20on%20Chromatographic%20-%20An%20Overview.pdf
8. Guideline ICH . Validation of Analytical Procedures: text and Methodology. Q2 (R1). 2005 Nov;(20):05. https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf
9. Guideline ICH . Stability testing of New Drug Substances and Products: Q1A(R2).2003 Feb;(06).https://database.ich.org/sites/default/files/Q1A%28R2%29%20Guideline.pdf

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