zhpsЖурнал прикладной спектроскопииZhurnal Prikladnoii Spektroskopii0514-7506B. I. Stepanov Institute of Physics of the National Academy of Scienceszhps-1110Research ArticleАННОТАЦИИ АНГЛОЯЗЫЧНЫХ СТАТЕЙABSTRACTS ENGLISH-LANGUAGE ARTICLESСпектрофотометрический метод определения варденафила в чистом виде и лекарственных формахDetermination of Vardenafil in Pure and Dosage Forms by SpectrophotometryRoopaK. P.RoopaK. P.

Бангалор

Bengaluru

roopakp@sapthagiri.edu.inKeshavamurthyK.KeshavamurthyK.

Бангалор

Bengaluru

MahesB.MaheshB.

Бангалор

Bengaluru

VeenaK. P.VeenaK. P.

Хассан

Hassan

ShankaraB. S.ShankaraB. S.

Бангалор

Bengaluru

BasavaiahK.BasavaiahK.

Майсур

Manasagangothri, Mysore

Инженерный колледж СаптагириИндияSapthagiri Сollege of EngineeringIndiaТехнологический институт ВивеканандыИндияVivekananda Institute of TechnologyIndiaАкадемия технического образования JSSИндияJSS Academy of Technical EducationIndiaТехнологический институт РадживаИндияRajeev Institute of TechnologyIndiaТехнологический институт Шри КришныИндияSri Krishna Institute of TechnologyIndiaУниверситет Майсура, МанасаганготриИндияUniversity of MysoreIndia202228072022894599599Copyright © Roopa K.P., Keshavamurthy K., Mahes B., Veena K.P., Shankara B.S., Basavaiah K., 20222022Roopa K.P., Keshavamurthy K., Mahes B., Veena K.P., Shankara B.S., Basavaiah K.Roopa K.P., Keshavamurthy K., Mahesh B., Veena K.P., Shankara B.S., Basavaiah K.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://zhps.ejournal.by/jour/article/view/1110

Для анализа варденафила в фармацевтических препаратах разработаны и оптимизированы  три спектрофотометрических метода. Варденафил окисляется небольшим избытком N-бромсукцинимида (NBS), и непрореагировавший оксидант оценивается путем определения количества неизрасходованного NBS в реакциях с фиксированным количеством сафранина (метод A), кристаллического фиолетового (метод B) и анилинового синего (метод C) в кислой среде по измерениям оптической плотности при 530, 600 и 610 нм соответственно. Для всех методов количество потребляемого NBS соответствует количеству лекарственного препарата. Рассчитаны диапазон выполнимости закона Бера, чувствительность Сэнделла и коэффициенты молярной экстинкции 1.1104×104, 1.0305×104 и 6.217×103 л/моль · см для методов А, В и С соответственно. Оценены пределы обнаружения и количественного определения. Методы также оценены статистически с помощью  t-критерия Стьюдента и F-критерия. Результаты показывают отличное совпадение и незначительное различие между эталонным и предложенными методами. Разработанные методы успешно применены для анализа варденафила в чистом виде и лекарственных формах.

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. 

лекарственное средствоN-бромсукцинимидокислительно-восстановительная реакцияварденафилУФ-видимая спектроскопияdrug researchN-bromosuccinimideredox reactionvardenafilUV-Vis spectroscopyReferencesG. M. Keating, L. J. Scott, Drugs, 63, 2673–2703 (2003).G. M. Keating, L. J. Scott, Drugs, 63, 2673–2703 (2003).Z. D. Bartosova, A. Jirovsky, Horna, J. Chromatogr. A, 1218, 7996–8001 (2011), doi: 10.1016/j.chroma.2011.09.001 PMID: 21943935.Z. D. Bartosova, A. Jirovsky, Horna, J. Chromatogr. A, 1218, 7996–8001 (2011), doi: 10.1016/j.chroma.2011.09.001 PMID: 21943935.J. D. Corbin, A. Beasley, M. A. Blount, S. H. Francis, Neurochem. Int., 45, 859–863 (2004), doi: 10.1016/j.neuint.2004.03.016J. D. Corbin, A. Beasley, M. A. Blount, S. H. Francis, Neurochem. Int., 45, 859–863 (2004), doi: 10.1016/j.neuint.2004.03.016S. Khalil, Microchim. Acta, 158, 233–238 (2007), doi: 10.1007/s00604-006-0706-7.S. Khalil, Microchim. Acta, 158, 233–238 (2007), doi: 10.1007/s00604-006-0706-7.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.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.B. B. Uslu, S. A. Dogan, Ozkan, Anal. Chim. Acta, 552, 127–134 (2005), doi: 10.1016/j.aca.2005.07.040.B. B. Uslu, S. A. Dogan, Ozkan, Anal. Chim. Acta, 552, 127–134 (2005), doi: 10.1016/j.aca.2005.07.040.I. Papoutsis, P. Nikolaou, S. Athanaselis, C. Pistos, et al., Mass. Spectrom., 46, 71–76 (2011), doi: 10.1002/jms.1868 PMID: 21184398I. Papoutsis, P. Nikolaou, S. Athanaselis, C. Pistos, et al., Mass. Spectrom., 46, 71–76 (2011), doi: 10.1002/jms.1868 PMID: 21184398S. Strano-Rossi, L. Anzillotti, X. De la Torre, et al., Rapid. Comm. Mass. Spectrom., 24, 1697–1706 (2010).S. Strano-Rossi, L. Anzillotti, X. De la Torre, et al., Rapid. Comm. Mass. Spectrom., 24, 1697–1706 (2010).S. T. Lake, P. M. Altman, J. Vaisman, et al., Biomed. Chromatogr., 24, 846–851 (2010), doi: 10.1002/bmc.1375.S. T. Lake, P. M. Altman, J. Vaisman, et al., Biomed. Chromatogr., 24, 846–851 (2010), doi: 10.1002/bmc.1375.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.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.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.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.Chiranjeevi Rishitha, Kirti Kumari Sharma, Vegesna Swetha, Vaidya Jayathirtha Rao, World J. Pharm. Pharm. Sci., 5, 1109–1136 (2018), doi: 10.20959/wjpps201612-8241.Chiranjeevi Rishitha, Kirti Kumari Sharma, Vegesna Swetha, Vaidya Jayathirtha Rao, World J. Pharm. Pharm. Sci., 5, 1109–1136 (2018), doi: 10.20959/wjpps201612-8241.N. Mital, S. Patel, Charmy, Kothari, Curr. Anal. Chem., 16, 263–276 (2020), doi: 10.2174/1573411014666180501122512.N. Mital, S. Patel, Charmy, Kothari, Curr. Anal. Chem., 16, 263–276 (2020), doi: 10.2174/1573411014666180501122512.Bhargav Patel, Anjani Chaudhari, Rajashree Mashru, World J. Pharm. Pharm. Sci., 6, 1039–1049 (2017).Bhargav Patel, Anjani Chaudhari, Rajashree Mashru, World J. Pharm. Pharm. Sci., 6, 1039–1049 (2017).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.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.Khaled El-Refai, Mahmoud H. Teaima, Mohamed A. El-Nabarawi, Drug. Develop. Ind. Pharm., 44, 988–1000 (2018), doi: 10.1080/03639045.2018.1427761.Khaled El-Refai, Mahmoud H. Teaima, Mohamed A. El-Nabarawi, Drug. Develop. Ind. Pharm., 44, 988–1000 (2018), doi: 10.1080/03639045.2018.1427761.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.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.Ragaa El Shiekh, Alaa S. Amin, Eman M. Hafez, Ayman A. Gouda, Der. Pharm. Lett., 8, 153–165 (2016).Ragaa El Shiekh, Alaa S. Amin, Eman M. Hafez, Ayman A. Gouda, Der. Pharm. Lett., 8, 153–165 (2016).Amir Alhaj Sakur, Shaza Affas, Int. J. Pharm. Pharm. Sci., 9, 65–69 (2017).Amir Alhaj Sakur, Shaza Affas, Int. J. Pharm. Pharm. Sci., 9, 65–69 (2017).Eman M. Hafez, Ragaa El Shiekh, Alaa S. Amin, Ayman A. Gouda, Chem. Sci. Trans., 5, 836–851 (2016), doi: 10.7598/cst2016.1271.Eman M. Hafez, Ragaa El Shiekh, Alaa S. Amin, Ayman A. Gouda, Chem. Sci. Trans., 5, 836–851 (2016), doi: 10.7598/cst2016.1271.Ragaa El Shiekh, Alaa S. Amin, Eman M. Hafez, Ayman A. Gouda, Chem. Sci. Trans., 5, 962–978 (2016), doi: 10.7598/cst2016.1280.Ragaa El Shiekh, Alaa S. Amin, Eman M. Hafez, Ayman A. Gouda, Chem. Sci. Trans., 5, 962–978 (2016), doi: 10.7598/cst2016.1280.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.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.Atkuru Veera Venkata Naga Krishna Sunil Kumar, Chandra Bala Sekaran, Tamanampudi Varahala Reddy, Int. J. Chem. Biomol. Sci., 1, 185–192 (2015).Atkuru Veera Venkata Naga Krishna Sunil Kumar, Chandra Bala Sekaran, Tamanampudi Varahala Reddy, Int. J. Chem. Biomol. Sci., 1, 185–192 (2015).Bhavin Chapla, Gunjan Amin, Ashutosh Pandya, Jagdish Kakadiya, Nehal Shah, Int. Res. J. Pharm., 3, 480–483 (2012).Bhavin Chapla, Gunjan Amin, Ashutosh Pandya, Jagdish Kakadiya, Nehal Shah, Int. Res. J. Pharm., 3, 480–483 (2012).K. P. Roopa, B. K. Jayanna, P. Nagaraja, Anal. Chem. Lett., 6, 143–152 (2016), doi: 10.1080/22297928.2016.1191970.K. P. Roopa, B. K. Jayanna, P. Nagaraja, Anal. Chem. Lett., 6, 143–152 (2016), doi: 10.1080/22297928.2016.1191970.K. P. Roopa, B. K. Jayanna, P. Nagaraja, Int. J. Pharm. Sci. Rev. Res., 32, 55–60 (2015).K. P. Roopa, B. K. Jayanna, P. Nagaraja, Int. J. Pharm. Sci. Rev. Res., 32, 55–60 (2015).K. P. Roopa, K. Basavaiah, B. S. Shankara, B. Mahesh, J. Appl. Spectrosc., 87, 1021–1031 (2020), doi: 10.1007/s10812-021-01126-2.K. P. Roopa, K. Basavaiah, B. S. Shankara, B. Mahesh, J. Appl. Spectrosc., 87, 1021–1031 (2020), doi: 10.1007/s10812-021-01126-2.K. P. Roopa, K. Basavaiah, B. K. Jayanna, J. Appl. Spectrosc., 86, 740–747 (2019), doi: 10.1007/s10812-019-00888-029.K. P. Roopa, K. Basavaiah, B. K. Jayanna, J. Appl. Spectrosc., 86, 740–747 (2019), doi: 10.1007/s10812-019-00888-029.K. P. Roopa, B. K. Jayanna, P. Nagaraja, Int. J. Bio. Pharm. Res., 6, 56–62 (2015).K. P. Roopa, B. K. Jayanna, P. Nagaraja, Int. J. Bio. Pharm. Res., 6, 56–62 (2015).K. Basavaiah, B. C. Somashekar, J. Chem., 4, 117–127 (2007), doi: 10.1155/2007/739141.K. Basavaiah, B. C. Somashekar, J. Chem., 4, 117–127 (2007), doi: 10.1155/2007/739141.K. N. Prashanth, K. Basavaiah, M. S. Raghu, Int. J. Anal. Chem., 934357 (2013), PMID: 23935625, doi: 10.1155/2013/934357.K. N. Prashanth, K. Basavaiah, M. S. Raghu, Int. J. Anal. Chem., 934357 (2013), PMID: 23935625, doi: 10.1155/2013/934357.A. Berka, J. Vulterin, J. Zyoka, Newer Redox Titrants, New York, USA, Pergamon Press (1965).A. Berka, J. Vulterin, J. Zyoka, Newer Redox Titrants, New York, USA, Pergamon Press (1965).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).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).

The authors declare that there are no conflicts of interest present.