zhpsЖурнал прикладной спектроскопииZhurnal Prikladnoii Spektroskopii0514-7506B. I. Stepanov Institute of Physics of the National Academy of Scienceszhps-1137Research ArticleСтатьиУФ-СПЕКТРОФОТОМЕТРИЧЕСКИЙ МЕТОД ОДНОВРЕМЕННОГО ОПРЕДЕЛЕНИЯ ПРОТИВОТУБЕРКУЛЕЗНЫХ ПРЕПАРАТОВ В МОДЕЛИРУЕМОЙ ЖИДКОСТИ АЛЬВЕОЛЯРНЫХ МАКРОФАГОВ ЛЕГКИХSIMULTANEOUS DETERMINATION AND VALIDATION OF ANTI-TUBERCULAR DRUGS IN SIMULATED LUNGS ALVEOLAR MACROPHAGES FLUID BY ULTRAVIOLET-VISIBLE SPECTROPHOTOMETRIC METHODBhoyarV.BhoyarV.

Нагпур

Vidyadevi Bhoyar

Nagpur

vidyadevi.bhoyar@yahoo.comBelgamwarV. S.BelgamwarV. S.

Нагпур

Veena S. Belgamwar

Nagpur

TrivediS.TrivediS.

Нагпур

Sagar Trivedi

Nagpur

Университет Раштрасанта Тукадоджи Махараджа Нагпура, Махатма Джотиба Фулей Шайкшаник ПарисарDepartment of Pharmaceutical Sciences, Rashtrasant Tukadoji Maharaj Nagpur University, Mahatma Jyotiba Fuley Shaikshanik Parisar202226092022895688693Copyright © Bhoyar V., Belgamwar V.S., Trivedi S., 20222022Bhoyar V., Belgamwar V.S., Trivedi S.Bhoyar V., Belgamwar V.S., Trivedi 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/1137

Разработан спектрофотометрический метод в ультрафиолетовой и видимой области спектра (UV-Vis) для одновременного определения изониазида (INH) и рифампицина (RIF) с использованием метода Виродта. Наряду с метанолом выбраны два других растворителя — фосфатный буфер с рН 7.4 и цитро-фосфатный буфер с рН 5.0, первый из которых моделирует рН эпителиальной жидкости слизистой оболочки легких, а второй — фаголизосомальной среды. Выбрано соотношение 1:1.5 чистого лекарственного средства INH:RIF. Выявлены схожие максимумы поглощения в трех растворителях, и поэтому выбраны максимумы поглощения при 263 и 335 нм INH и RIF. Калибровочная кривая в диапазоне концентраций 4–24 мкг/мл INH и 6–36 мкг/мл RIF подчиняется закону Ламберта–Бера. Метод проверен с точки зрения линейности, чувствительности и достоверности в соответствии с рекомендациями ICH.

An ultraviolet-visible (UV-Vis) spectrophotometric method was developed for the simultaneous determination of isoniazid (INH) and rifampicin (RIF) using Vierordt’s method. In this method, along with methanol, two other solvents such as phosphate buffer pH 7.4 and citro-phosphate buffer pH 5.0 were also selected, the former of which is simulated with the pH of lung epithelial lining fluid and the latter is simulated with the phagolysosomal environment. A 1:1.5 ratio of pure INH:RIF was selected and scanned, which showed similar absorption maxima at three solvents, and on that basis absorption maxima at 263 and 335 nm of INH and RIF, respectively, were selected. A calibration curve within the concentration ranges between 4 and 24 µg/mL of INH and 6–36 µg/mL of RIF follows the Beer–Lambert law. It was validated with respect to linearity, sensitivity, precision, and accuracy according to International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use guidelines.

изониазидрифампицинодновременное определениеУФ-видимая спектрофотометрияisoniazidrifampicinsimultaneous determinationUV-Vis spectrophotometryThe authors would like to acknowledge Chhatrapati Shahu Maharaj Research, Training and Human Development Institute (SARTHI), Pune, Maharashtra, India, for providing financial support to Vidyadevi Bhoyar through Chhatrapati Shahu Maharaj National Research Fellowship (CSMNRF2019). The authors would also like to thank Lupin Limited, Chikalthana, Aurangabad, Maharashtra, India, for providing gratis samples.ReferencesWorld Health Organisation, End TB Strategy, World Health Organization, 53, 1689–1699 (2013).World Health Organisation, End TB Strategy, World Health Organization, 53, 1689–1699 (2013).CDC fact sheet, Tuberculosis : An Overview, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Centers, 2014. Assessed on 10th sept 2021 at https://www.cdc.gov/tb/publications/factsheets/general/tb.htm#:~:text=Tuberculosis%20(TB)%20is%20a%20disease,they%20do%20not%20get%20treatment.CDC fact sheet, Tuberculosis : An Overview, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Centers, 2014. Assessed on 10th sept 2021 at https://www.cdc.gov/tb/publications/factsheets/general/tb.htm#:~:text=Tuberculosis%20(TB)%20is%20a%20disease,they%20do%20not%20get%20treatment.S. D. A. Burke, Rev. Anthropol., 40, 27–52 (2011), doi: 10.1080/00938157.2011.547754.S. D. A. Burke, Rev. Anthropol., 40, 27–52 (2011), doi: 10.1080/00938157.2011.547754.S. M. Swain, I. C. Behera, Egypt. J. Ear, Nose, Throat Allied Sci., 18, 237–240 (2017).S. M. Swain, I. C. Behera, Egypt. J. Ear, Nose, Throat Allied Sci., 18, 237–240 (2017).M. Tilinca, G. Hancu, E. Mircia, D. Iriminescu, A. Rusu, R. A. Vlad, E. Barabás, Farmacia, 65, 219–224 (2017).M. Tilinca, G. Hancu, E. Mircia, D. Iriminescu, A. Rusu, R. A. Vlad, E. Barabás, Farmacia, 65, 219–224 (2017).U. Shah, A. Jasani, Int. J. Pharm. Pharm. Sci., 6, 274–280 (2014).U. Shah, A. Jasani, Int. J. Pharm. Pharm. Sci., 6, 274–280 (2014).Interactive Core Curriculum on Tuberculosis, Chapter 6 Treatment of Tuberculosis Disease, Centers for Disease Control and Prevention 1600 Clifton Rd. Atlanta GA 30329, USA, Assessed on 1st Sept 2021 at https://www.cdc.gov/tb/education/corecurr/pdf/chapter6.pdfInteractive Core Curriculum on Tuberculosis, Chapter 6 Treatment of Tuberculosis Disease, Centers for Disease Control and Prevention 1600 Clifton Rd. Atlanta GA 30329, USA, Assessed on 1st Sept 2021 at https://www.cdc.gov/tb/education/corecurr/pdf/chapter6.pdfB. Prasanthi, J. V. Ratna, R. S. C. Phani, J. Anal. Chem., 70, 1015–1022 (2015).B. Prasanthi, J. V. Ratna, R. S. C. Phani, J. Anal. Chem., 70, 1015–1022 (2015).M. A. O. Mohamed, S. W. Shantier, M. A. Mohamed, E. A. Gadkariem, E. M. O. Ismail, Int. J. Pharm. Sci. Rev. Res., 32, 154–156 (2015).M. A. O. Mohamed, S. W. Shantier, M. A. Mohamed, E. A. Gadkariem, E. M. O. Ismail, Int. J. Pharm. Sci. Rev. Res., 32, 154–156 (2015).S. K. Arifa Begum, D. Basava Raju, N. Rama Rao, Der Pharm. Lett., 5, 419–426 (2013).S. K. Arifa Begum, D. Basava Raju, N. Rama Rao, Der Pharm. Lett., 5, 419–426 (2013).L. Cunha, A. M. Rosa da Costa, J. P. Lourenço, F. Buttini, A. Grenha, J. Microencapsul., 35, 392–405 (2018), doi:10.1080/02652048.2018.1513089.L. Cunha, A. M. Rosa da Costa, J. P. Lourenço, F. Buttini, A. Grenha, J. Microencapsul., 35, 392–405 (2018), doi:10.1080/02652048.2018.1513089.J. B. S. A. H. Beckett, In: Pract. Pharm. Chem., pt. II, 4th Ed., ch. 7, CBS Publishers & Distributors Pvt. Ltd., 257–337 (2007).J. B. S. A. H. Beckett, In: Pract. Pharm. Chem., pt. II, 4th Ed., ch. 7, CBS Publishers & Distributors Pvt. Ltd., 257–337 (2007).The Indian Pharmacopoeia Commission, Indian Pharmacopoeia, 1, 241–243 (2007).The Indian Pharmacopoeia Commission, Indian Pharmacopoeia, 1, 241–243 (2007).Rifampicin and Isoniazid Tablets: Revised Draft Proposal for the International Pharmacopoeia (October 2005), World health organization (2005).Rifampicin and Isoniazid Tablets: Revised Draft Proposal for the International Pharmacopoeia (October 2005), World health organization (2005).Guidance for Industry Q2B Validation of Analytical Procedures: Methodology (1996), http://www.fda.gov/cder/guidance/index.htmorhttp://www.fda.gov/cber/guidelines.htm, accessed 20 October (2021).Guidance for Industry Q2B Validation of Analytical Procedures: Methodology (1996), http://www.fda.gov/cder/guidance/index.htmorhttp://www.fda.gov/cber/guidelines.htm, accessed 20 October (2021).

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