zhpsЖурнал прикладной спектроскопииZhurnal Prikladnoii Spektroskopii0514-7506B. I. Stepanov Institute of Physics of the National Academy of Scienceszhps-1018Research ArticleАННОТАЦИИ АНГЛОЯЗЫЧНЫХ СТАТЕЙABSTRACTS ENGLISH-LANGUAGE ARTICLESРазработка и валидация чувствительного спектрофлуориметрического метода определения ибрутинибаDevelopment and Validation of a Sensitive Spectrofluorimetric Method for the Determination of IbrutinibMondalB.MondalB.

Чандигарх

Chandigarh

BaliA.BaliA.

Чандигарх

Chandigarh

alka.bali@rediffmail.comИнститут фармацевтических наук, Центр перспективных исследований UGC Университета ПанджабаUniversity Institute of Pharmaceutical Sciences, UGC Center of Advanced Study, Panjab University202224032022892288288Copyright © Mondal B., Bali A., 20222022Mondal B., Bali A.Mondal B., Bali A.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/1018

Разработан воспроизводимый, чувствительный и экономичный спектрофлуориметрический метод для количественного определения лекарственного средства ибрутиниба в нерасфасованной и пероральной капсульной формах. Проверка метода в соответствии с руководящими принципами ICH показала его высокую чувствительность, отличную линейность в диапазоне концентраций 0.1–7.5 мкг/мл с коэффициентом корреляции r2 = 0.9961, LOD и LOQ 0.224 и 0.680 мкг/мл. Извлечение лекарственного средства из капсульной композиции по предлагаемому способу 97.59, 1.42 % RSD.

A reproducible, sensitive, and cost-effective spectrofluorimetric method has been developed for quantification of the drug ibrutinib in bulk and in its oral capsule formulation. The method was validated in accordance with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use guidelines with respect to linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), and robustness. The method was found to be extremely sensitive, and excellent linearity was noted within the concentration range 0.1–7.5 μg/mL with a correlation coefficient (r2) of 0.9961. The LOD and LOQ values for the proposed method were found to be 0.224 and 0.680 μg/mL, respectively. Excellent recoveries of the drug were observed from the marketed capsule formulation by the proposed method (97.59, 1.42% relative standard deviation).

ибрутинибспектрофлуориметриявалидацияанализibrutinibspectrofluorimetryvalidationanalysisWe sincerely thank Cipla Limited (Mumbai, India) for graciously providing us with pure samples of ibrutinib.We sincerely thank Cipla Limited (Mumbai, India) for graciously providing us with pure samples of ibrutinib.ReferencesE. D. Deeks, Drugs, 77, 225–236 (2017).E. D. Deeks, Drugs, 77, 225–236 (2017).S. Molica, E. Matutes, C. Tam, A. Polliack, Hematol. Oncol., 38, 129–136 (2020).S. Molica, E. Matutes, C. Tam, A. Polliack, Hematol. Oncol., 38, 129–136 (2020).S. Veeraraghavan, S. Viswanadha, S. Thappali, B. Govindarajulu, S. Vakkalanka, M. Rangasamy, J. Pharm. Biomed. Anal., 107, 151–158 (2015).S. Veeraraghavan, S. Viswanadha, S. Thappali, B. Govindarajulu, S. Vakkalanka, M. Rangasamy, J. Pharm. Biomed. Anal., 107, 151–158 (2015).J. J. M. Rood, S. van Hoppe, A. H. Schinkel, J. H. M. Schellens, J. H. Beijnen, R. W. Sparidans, J. Pharm. Biomed. Anal., 118, 123–131 (2016).J. J. M. Rood, S. van Hoppe, A. H. Schinkel, J. H. M. Schellens, J. H. Beijnen, R. W. Sparidans, J. Pharm. Biomed. Anal., 118, 123–131 (2016).D. Beauvais, J. F. Goossens, E. Boyle, B. Allal, T. Lafont, E. Chatelut, C. Herbaux, F. Morschhauser, S. Genay, P. Odou, C. Danel, J. Chromatogr. B, 1093, 158–166 (2018).D. Beauvais, J. F. Goossens, E. Boyle, B. Allal, T. Lafont, E. Chatelut, C. Herbaux, F. Morschhauser, S. Genay, P. Odou, C. Danel, J. Chromatogr. B, 1093, 158–166 (2018).J. J. M. Rood, P. J. A. Dormans, M. J. van Haren, J. H. M. Schellens, J. H. Beijnen, R. W. Sparidans, J. Chromatogr. B, 1090, 14–21 (2018).J. J. M. Rood, P. J. A. Dormans, M. J. van Haren, J. H. M. Schellens, J. H. Beijnen, R. W. Sparidans, J. Chromatogr. B, 1090, 14–21 (2018).P. Du, Y. Guan, Z. An, P. Li, L. Liu, Analyst, 144, 5462–5471 (2019).P. Du, Y. Guan, Z. An, P. Li, L. Liu, Analyst, 144, 5462–5471 (2019).T. Yasu, K. Momo, H. Yasui, S. Kuroda, Biomed. Chromatogr., 33, e4435 (2019).T. Yasu, K. Momo, H. Yasui, S. Kuroda, Biomed. Chromatogr., 33, e4435 (2019).L.-M. Wei, Z.-X. Xu, P.-F. Lv, Y.-L. Xue, X.-X. Wang, M. Zhang, Lat. Am. J. Pharm., 35, 130–134 (2016).L.-M. Wei, Z.-X. Xu, P.-F. Lv, Y.-L. Xue, X.-X. Wang, M. Zhang, Lat. Am. J. Pharm., 35, 130–134 (2016).N. J. R. Hepsebah, A. A. Kumar, Int. J. Pharmacy Pharm. Sci., 11, 22–26 (2019).N. J. R. Hepsebah, A. A. Kumar, Int. J. Pharmacy Pharm. Sci., 11, 22–26 (2019).M. Iqbal, F. Shakeel, T. Anwer, J. AOAC Int., 99, 618–625 (2016).M. Iqbal, F. Shakeel, T. Anwer, J. AOAC Int., 99, 618–625 (2016).S. S. Prasad, G. K. Mohan, A.N. Babu, Anal. Methods, 12, 1434–1445 (2019).S. S. Prasad, G. K. Mohan, A.N. Babu, Anal. Methods, 12, 1434–1445 (2019).S. Vajjha, V. Bommuluri, C. S. Rumalla, R. Doddipalla, M. Kaliyaperumal, R.B. Korupolu, J. Pharm. Biomed. Anal., 172, 9–17 (2019).S. Vajjha, V. Bommuluri, C. S. Rumalla, R. Doddipalla, M. Kaliyaperumal, R.B. Korupolu, J. Pharm. Biomed. Anal., 172, 9–17 (2019).G. H. Bindu, M. M. Annapurna, Res. J. Pharm. Tech., 11, 4587–4591 (2018).G. H. Bindu, M. M. Annapurna, Res. J. Pharm. Tech., 11, 4587–4591 (2018).S. Kapavarapu, R. Golkonda, R. Chintala, Anal. Chem., 16, 7–19 (2016).S. Kapavarapu, R. Golkonda, R. Chintala, Anal. Chem., 16, 7–19 (2016).N. Konduru, R. Gundla, N. K. Katari, K. Paidikondala, A.S. Reddy, V. Jagadabi, Anal. Chem. Lett., 10, 113–136 (2020).N. Konduru, R. Gundla, N. K. Katari, K. Paidikondala, A.S. Reddy, V. Jagadabi, Anal. Chem. Lett., 10, 113–136 (2020).S. Illendula, D. Priyanka, V. Shirisha, K. N. V. Rao, R. Dutt, Int. J. Pharmacy Biol. Sci., 9, 36–46 (2019).S. Illendula, D. Priyanka, V. Shirisha, K. N. V. Rao, R. Dutt, Int. J. Pharmacy Biol. Sci., 9, 36–46 (2019).V. Uppala, N. Divya, E. Charishma, K. Harshavardan, Shyamala, M. Joginapally, Indo Am. J. Pharm. Sci., 3, 324–330 (2016).V. Uppala, N. Divya, E. Charishma, K. Harshavardan, Shyamala, M. Joginapally, Indo Am. J. Pharm. Sci., 3, 324–330 (2016).S. Muneer, H. A. Ahad, C. K. Bonnoth, J. Pharm. Res., 11, 712–718 (2017).S. Muneer, H. A. Ahad, C. K. Bonnoth, J. Pharm. Res., 11, 712–718 (2017).M. Fouad, M. Helvenstein, B. Blankert, J. Anal. Methods Chem., 2015, Article ID 215128 (2015).M. Fouad, M. Helvenstein, B. Blankert, J. Anal. Methods Chem., 2015, Article ID 215128 (2015).M. R. Reddy, K. Mishra, R. Suresh, Int. J. Pharm. Res. Health Sci., 6, 2303–2307 (2018).M. R. Reddy, K. Mishra, R. Suresh, Int. J. Pharm. Res. Health Sci., 6, 2303–2307 (2018).ICH, Validation of analytical procedures: text and methodology Q2 (R1), Int. Conf. Harmonization,ICH, Validation of analytical procedures: text and methodology Q2 (R1), Int. Conf. Harmonization,Geneva, Switzerland, 11, 1–13 (2005).Geneva, Switzerland, 11, 1–13 (2005).http://www.drugbank.ca/drugs/DB09053http://www.drugbank.ca/drugs/DB09053Z. Chen, J. Zhai, X. Liu, S. Mao, L. Zhang, S. Rohani, J. Lu, J. Chem. Thermodyn., 103, 342–348 (2016).Z. Chen, J. Zhai, X. Liu, S. Mao, L. Zhang, S. Rohani, J. Lu, J. Chem. Thermodyn., 103, 342–348 (2016).

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