zhpsЖурнал прикладной спектроскопииZhurnal Prikladnoii Spektroskopii0514-7506B. I. Stepanov Institute of Physics of the National Academy of Scienceszhps-1583Research ArticleАННОТАЦИИ АНГЛОЯЗЫЧНЫХ СТАТЕЙABSTRACTS ENGLISH-LANGUAGE ARTICLESСпектрофотометрические методы производных для определения иделалисиба в нерасфасованном виде и фармацевтических составахDerivative Spectrophotometric Methods for Determination of Idelalisib in Bulk and in FormulationMaheshM.MaheshM.

Чандигарх

UGC Center of Advanced Study,

Panjab University, Chandigarh

BaliA.BaliA.

Чандигарх

UGC Center of Advanced Study,

Panjab University, Chandigarh

alka.bali@rediffmail.comGuptaT.GuptaT.

Чандигарх

UGC Center of Advanced Study,

Panjab University, Chandigarh

ShekharS.ShekharS.

Чандигарх

UGC Center of Advanced Study,

Panjab University, Chandigarh

Центр перспективных исследований UGC Пенджабского университетаUniversity Institute of Pharmaceutical Sciences202431052024913469469Copyright © Mahesh M., Bali A., Gupta T., Shekhar S., 20242024Mahesh M., Bali A., Gupta T., Shekhar S.Mahesh M., Bali A., Gupta T., Shekhar S.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/1583

Иделалисиб представляет собой ингибитор фосфатидилинозитол-3-киназы дельта, одобренный FDA и EMA для лечения лимфолитической лимфомы, В-клеточной неходжкинской лимфомы и лимфоцитарной лимфомы. Предложен спектрофотометрический метод производных нулевого и первого порядка для оценки иделалисиба в нерасфасованном виде и фармацевтических составах. Предварительный спектрофотометрический анализ препарата проведен в метаноле, всего рассмотрено 12 параметрических вариаций. Три выбранных варианта метода (использующие поглощение, пик-ноль и пик-пик) оценены на стабильность, указывающую на потенциал лекарственного средства в растворах, разрушаемых под действием стресса. Разработанный метод проверен на линейность, точность, прецизионность и надежность. Линейность наблюдалась в диапазоне концентраций 1.0–60.0 мкг/мл с коэффициентом корреляции 0.9997. Для предложенных вариантов метода LOD = 0.42—3.11 мкг/мл и LOQ = 1.29—9.42 мкг/мл. Метод использован для количественного определения препарата в таблетированной форме, получены хорошие показатели извлечения в диапазоне 95.98—98.81%.

Idelalisib is a phosphatidylinositol 3-kinase delta inhibitor approved by the FDA and the EMA for the treatment of lympholytic lymphoma, B cell non-Hodgkin lymphoma, and lymphocytic lymphoma. The present report describes the validation of a simple, rapid, sensitive, and cost-effective zero-order and first-order derivative spectrophotometric method for the estimation of idelalisib in bulk and in its marketed formulation. Preliminary spectrophotometric analysis of the drug was carried out in methanol and a total of 12 parametric variations were considered. Three selected method variants employing peak-zero and peak-peak techniques were assessed for their stability indicating potential in stress degraded solutions of the drug. The developed method was validated with respect to linearity, accuracy, precision, and robustness. Excellent linearity was observed within the concentration range 1.0–60.0 μg/mL with a correlation coefficient of 0.9997. The limits of assay detection values were found for the range 0.42–3.11 μg/mL, and quantitation limits ranged from 1.29 to 9.42 μg/mL for the proposed method variants. The proposed method was used to quantify the drug in its marketed tablet formulation, and good recoveries ranging from 95.98 to 98.81% were obtained.

иделалисибпредел обнаруженияпредел количественного определенияidelalisiblimit of detectionlimit of quantificationThis work was supported by the University Grants Commission (UGC), New Delhi, India (Grant No. 36/N/296).ReferencesL. A. Raedler, Am. Health Drug Benefits., 8, 157–162 (2015).L. A. Raedler, Am. Health Drug Benefits., 8, 157–162 (2015).A. Davies, Expert Rev. Hematol., 8, No. 5, 581–593 (2015).A. Davies, Expert Rev. Hematol., 8, No. 5, 581–593 (2015).A. Markham, Drugs, 74, No. 14, 1701–1707 (2014).A. Markham, Drugs, 74, No. 14, 1701–1707 (2014).https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206545lBl.pdf (last time accessed: January 25, 2023).https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/20654 5lBl.pdf (last time accessed: January 25, 2023).Zydelig®. (Idelalisib). Highlights of prescribing information, https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206545lbl.pdf.Accessedon15November2020 (last time accessed: January 25, 2023).Zydelig®. (Idelalisib). Highlights of prescribing information, https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206545lbl.pdf.Accessedon15November2020 (last time accessed: January 25, 2023).ZYDELIG Product Information v4.0 (2017) https://www.tga.gov.au/sites/default/files/auspar-idelalisib171019-pi.pdf (last time accessed: February 21, 2022).ZYDELIG Product Information v4.0 (2017) https://www.tga.gov.au/sites/default/files/auspar-idelalisib171019-pi.pdf (last time accessed: February 21, 2022).R. R. Furman, J. P. Sharman, S. E. Coutre, B. D. Cheson, J. M. Pagel, P. Hillmen, J. C. Barrientos, A. D. Zelenetz, T. J. Kipps, I. Flinn, P. Ghia, H. Eradat, T. Ervin, N. Lamanna, B. Coiffier, A. R. Pettitt, S. Ma, S. Stilgenbauer, P. Cramer, M. Aiello, D. M. Jhonson, L. L. Miller, D. Li, T. M. Jahn, R. D. Dansey, M. Hallek, S. M. O’Brien, N. Engl. J. Med., 370, No. 11, 997–1007 (2014).R. R. Furman, J. P. Sharman, S. E. Coutre, B. D. Cheson, J. M. Pagel, P. Hillmen, J. C. Barrientos, A. D. Zelenetz, T. J. Kipps, I. Flinn, P. Ghia, H. Eradat, T. Ervin, N. Lamanna, B. Coiffier, A. R. Pettitt, S. Ma, S. Stilgenbauer, P. Cramer, M. Aiello, D. M. Jhonson, L. L. Miller, D. Li, T. M. Jahn, R. D. Dansey, M. Hallek, S. M. O’Brien, N. Engl. J. Med., 370, No. 11, 997–1007 (2014).H. K. Tripathy, N. V. S. Manju, S. Dittakavi, A. Zakkula, R. Mullangi, Drug Res., 71, No. 1, 36–42 (2021).H. K. Tripathy, N. V. S. Manju, S. Dittakavi, A. Zakkula, R. Mullangi, Drug Res., 71, No. 1, 36–42 (2021).H. H. Huynh, C. Roessle, H. Sauvageon, A. Ple, I. Madelaine, C. Thieblemont, S. Mourah, L. Goldwit, Ther. Drug Monit., 40, 237–244 (2018).H. H. Huynh, C. Roessle, H. Sauvageon, A. Ple, I. Madelaine, C. Thieblemont, S. Mourah, L. Goldwit, Ther. Drug Monit., 40, 237–244 (2018).A. Suneetha, D. Sharmila, Int. J. Pharm. Sci. Res., 7, No. 12, 4998(1–5) (2016).A. Suneetha, D. Sharmila, Int. J. Pharm. Sci. Res., 7, No. 12, 4998(1–5) (2016).S. Veeraraghavan, S. Thappali, S. Viswanadha, S. Nalla, S. Chennupati, M. Golla, S. Vakkalanka, M. Rangaswamy, J. Chromatogr., 949-950, 63–69 (2014).S. Veeraraghavan, S. Thappali, S. Viswanadha, S. Nalla, S. Chennupati, M. Golla, S. Vakkalanka, M. Rangaswamy, J. Chromatogr., 949-950, 63–69 (2014).C. Wang, F. Jia, Y. Zhang, Biomed. Chromatogr., 33, e4511 (2019).C. Wang, F. Jia, Y. Zhang, Biomed. Chromatogr., 33, e4511 (2019).B. B. Gabani, S. Dittakavi, P. K. Kurakula, U. Todmal, M. Zainuddin, R. K. Trivedi, R. Mullangi, Anal. Chem., 11, No. 2, 140–152 (2021).B. B. Gabani, S. Dittakavi, P. K. Kurakula, U. Todmal, M. Zainuddin, R. K. Trivedi, R. Mullangi, Anal. Chem., 11, No. 2, 140–152 (2021).V. Bommuluri, S. Vajjha, C. S. Rumalla, S. Kadari, R. Doddipalla, M. Kaliyaperumal, R. B. Korupolu, V. Choppela, Sep. Sci. Plus, 3, 330 (1—9) (2020).V. Bommuluri, S. Vajjha, C. S. Rumalla, S. Kadari, R. Doddipalla, M. Kaliyaperumal, R. B. Korupolu, V. Choppela, Sep. Sci. Plus, 3, 330 (1—9) (2020).ICH, Validation of analytical procedures: text and methodology Q2 (R1), in International conference on harmonization, Geneva, Switzerland 11, 1–13 (2005).ICH, Validation of analytical procedures: text and methodology Q2 (R1), in International conference on harmonization, Geneva, Switzerland 11, 1–13 (2005).

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