|Generate QR code
Open Access
Subscription Access
Determination of Vardenafil in Pure and Dosage Forms by Spectrophotometry
Abstract
Three simple, sensitive, precise, and rapid spectrophotometric methods are developed and optimized for the assay of vardenafil in pharmaceutical formulations. The procedures are ascertained on the oxidation of vardenafil with a slight excess of N-bromosuccinimide (NBS), and the unreacted oxidant is estimated by evaluating the amount of the unconsumed NBS by reacting with a fixed amount of safranin (method A), crystal violet (method B), and aniline blue (method C) in an acidic medium by measuring the absorbance at 530, 600, and 610 nm, respectively. In all the methods, the amount of NBS consumed corresponds to the amount of the drug. Beer’s law range, Sandell’s sensitivity, and the corresponding molar absorptivity values of 1.1104×104, 1.0305×104, and 6.217×103 L/mol cm for methods A, B, and C are calculated. The limits of detection and quantification are evaluated. The methods are also evaluated statistically by means of Student’s t-test and F-test. The results show excellent agreement and insignificant difference between the proposed methods and the reference method. The developed methods are successfully applied to the assay of Vardenafil in pure and dosage forms, and no interference is observed from common excipients present in pharmaceutical formulations.
About the Authors
K. P. Roopa
Sapthagiri Сollege of Engineering
India
India
Bengaluru
K. Keshavamurthy
Vivekananda Institute of Technology
India
India
Bengaluru
B. Mahesh
JSS Academy of Technical Education
India
India
Bengaluru
K. P. Veena
Rajeev Institute of Technology
India
India
Hassan
B. S. Shankara
Sri Krishna Institute of Technology
India
India
Bengaluru
K. Basavaiah
University of Mysore
India
India
Manasagangothri, Mysore
References
1. G. M. Keating, L. J. Scott, Drugs, 63, 2673–2703 (2003).
2. Z. D. Bartosova, A. Jirovsky, Horna, J. Chromatogr. A, 1218, 7996–8001 (2011), doi: 10.1016/j.chroma.2011.09.001 PMID: 21943935.
3. J. D. Corbin, A. Beasley, M. A. Blount, S. H. Francis, Neurochem. Int., 45, 859–863 (2004), doi: 10.1016/j.neuint.2004.03.016
4. S. Khalil, Microchim. Acta, 158, 233–238 (2007), doi: 10.1007/s00604-006-0706-7.
5. J. R. Flores, J. B. Nevado, G. C. Penalvo, N. M. Diez, J. Chromatogr. B, 811, 231–236 (2004), doi: 10.1016/j.jchromb.2004.07.016.
6. B. B. Uslu, S. A. Dogan, Ozkan, Anal. Chim. Acta, 552, 127–134 (2005), doi: 10.1016/j.aca.2005.07.040.
7. I. Papoutsis, P. Nikolaou, S. Athanaselis, C. Pistos, et al., Mass. Spectrom., 46, 71–76 (2011), doi: 10.1002/jms.1868 PMID: 21184398
8. S. Strano-Rossi, L. Anzillotti, X. De la Torre, et al., Rapid. Comm. Mass. Spectrom., 24, 1697–1706 (2010).
9. S. T. Lake, P. M. Altman, J. Vaisman, et al., Biomed. Chromatogr., 24, 846–851 (2010), doi: 10.1002/bmc.1375.
10. K. K. Kumar, C. K. Rao, Y. R. K. Reddy, et al., Am. J. Anal. Chem., 3, 59–66 (2012), doi: 10.4236/ajac.2012.31009.
11. X. Zhu, S. Xiao, B. Chen, F. Zhang, S. Yao, et al., J. Chromatogr. A, 1066, 89–95 (2005), doi: 10.1016/j.chroma.2005.01.038.
12. Chiranjeevi Rishitha, Kirti Kumari Sharma, Vegesna Swetha, Vaidya Jayathirtha Rao, World J. Pharm. Pharm. Sci., 5, 1109–1136 (2018), doi: 10.20959/wjpps201612-8241.
13. N. Mital, S. Patel, Charmy, Kothari, Curr. Anal. Chem., 16, 263–276 (2020), doi: 10.2174/1573411014666180501122512.
14. Bhargav Patel, Anjani Chaudhari, Rajashree Mashru, World J. Pharm. Pharm. Sci., 6, 1039–1049 (2017).
15. Kaviraj Yarbagi, Nagaraju Rajana, J. Moses Babu, B. Venkateswara Rao, Paul Douglas, Int. J. Pharm. Sci. Res., 8, 107–119 (2017), doi: 10.13040/IJPSR.0975-8232.
16. Khaled El-Refai, Mahmoud H. Teaima, Mohamed A. El-Nabarawi, Drug. Develop. Ind. Pharm., 44, 988–1000 (2018), doi: 10.1080/03639045.2018.1427761.
17. M. M. Mabrouk, A. A. Gouda, S. F. El-Malla, D. S. Abdel Haleem, Ann. Pharm. Franc., 79, 16–27 (2020), doi: 10.1016/j.pharma.2020.08.003 PMID: 32853573.
18. Ragaa El Shiekh, Alaa S. Amin, Eman M. Hafez, Ayman A. Gouda, Der. Pharm. Lett., 8, 153–165 (2016).
19. Amir Alhaj Sakur, Shaza Affas, Int. J. Pharm. Pharm. Sci., 9, 65–69 (2017).
20. Eman M. Hafez, Ragaa El Shiekh, Alaa S. Amin, Ayman A. Gouda, Chem. Sci. Trans., 5, 836–851 (2016), doi: 10.7598/cst2016.1271.
21. Ragaa El Shiekh, Alaa S. Amin, Eman M. Hafez, Ayman A. Gouda, Chem. Sci. Trans., 5, 962–978 (2016), doi: 10.7598/cst2016.1280.
22. A. V. V. N. K. Sunil Kumara, T. V. Reddy, C. B. Sekaran, Anal. Bioanal. Chem. Res., 3, 29–39 (2016), doi: 10.22036/abcr.2016.13306.
23. Atkuru Veera Venkata Naga Krishna Sunil Kumar, Chandra Bala Sekaran, Tamanampudi Varahala Reddy, Int. J. Chem. Biomol. Sci., 1, 185–192 (2015).
24. Bhavin Chapla, Gunjan Amin, Ashutosh Pandya, Jagdish Kakadiya, Nehal Shah, Int. Res. J. Pharm., 3, 480–483 (2012).
25. K. P. Roopa, B. K. Jayanna, P. Nagaraja, Anal. Chem. Lett., 6, 143–152 (2016), doi: 10.1080/22297928.2016.1191970.
26. K. P. Roopa, B. K. Jayanna, P. Nagaraja, Int. J. Pharm. Sci. Rev. Res., 32, 55–60 (2015).
27. K. P. Roopa, K. Basavaiah, B. S. Shankara, B. Mahesh, J. Appl. Spectrosc., 87, 1021–1031 (2020), doi: 10.1007/s10812-021-01126-2.
28. K. P. Roopa, K. Basavaiah, B. K. Jayanna, J. Appl. Spectrosc., 86, 740–747 (2019), doi: 10.1007/s10812-019-00888-029.
29. K. P. Roopa, B. K. Jayanna, P. Nagaraja, Int. J. Bio. Pharm. Res., 6, 56–62 (2015).
30. K. Basavaiah, B. C. Somashekar, J. Chem., 4, 117–127 (2007), doi: 10.1155/2007/739141.
31. K. N. Prashanth, K. Basavaiah, M. S. Raghu, Int. J. Anal. Chem., 934357 (2013), PMID: 23935625, doi: 10.1155/2013/934357.
32. A. Berka, J. Vulterin, J. Zyoka, Newer Redox Titrants, New York, USA, Pergamon Press (1965).
33. ICH Steering Committee. ICH harmonized tripartite guideline, Validation of analytical procedures, text and methodology: Q2(R1) In: Proc. Int. Conf. on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, London, UK, November 1996 (1996).
Review
For citations:
Roopa K.P., Keshavamurthy K., Mahesh B., Veena K.P., Shankara B.S., Basavaiah K. Determination of Vardenafil in Pure and Dosage Forms by Spectrophotometry. Zhurnal Prikladnoii Spektroskopii. 2022;89(4):599.
Views: 271
Email this article 