zhpsЖурнал прикладной спектроскопииZhurnal Prikladnoii Spektroskopii0514-7506B. I. Stepanov Institute of Physics of the National Academy of Scienceszhps-1055Research ArticleСтатьиУФ-спектрофотометрический метод определения гидрохлорида амитриптилинаUltraviolet Spectrophotometric Method for the Determination of Amitriptyline HydrochlorideKumarD. A.Durai Ananda KumarT.

Майсуру, Карнатака

Mysuru, Karnataka

tduraianandakumar@jssuni.edu.inHaqueM. S.Simon HaqueMd.

Майсуру, Карнатака

Mysuru, Karnataka

Фармацевтический колледж Академии высшего образования и исследований JSSDepartment of Pharmaceutical Chemistry, JSS College of Pharmacy, Mysuru, JSS Academy of Higher Education & Research202225052022893374380Copyright © Kumar D.A., Haque M.S., 20222022Kumar D.A., Haque M.S.Durai Ananda Kumar T., Simon Haque M.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/1055

Предложен спектрофотометрический метод количественного определения амитриптилина гидрохлорида (АМГ) в водной среде без использования хромогенных условий. Метод проверен в соответствии с рекомендациями Международной конференции по гармонизации (ICH) Q2A. Для АМГ получено λmax = 239 нм. Линейность метода в диапазоне 0.5–2.5 мкг/мл при коэффициенте корреляции r2 = 0.9949 свидетельствует о более высокой чувствительности обнаружения АМГ по сравнению с известными спектрофотометрическими методами. Данные о процентном восстановлении (98–102%), точность, предел обнаружения (LOD) 0.0266 мкг/мл и предел количественного определения (LOQ) 0.0806 мкг/мл также указывают на его эффективность. Исследования вынужденной деградации под действием различных внешних факторов свидетельствуют о возможности использования предложенного метода для рутинного анализа. Метод расширен для количественного определения АМГ в коммерческих препаратах.

Amitriptyline hydrochloride (AMH) is a first-generation tricyclic antidepressant drug. Higher doses of AMH may lead to undesirable clinical conditions such as cardiac arrhythmia, anxiety (sleep disturbances), tachycardia, convulsion, and hyperglycemia. Hence, the accurate analytical method for the quantification of AMH is crucial. The reported AMH quantification methods are less sensitive and require chromogenic reactions. A newly developed spectrophotometric method for the quantification of AMH in the aqueous medium (greener) without using chromogenic conditions is reported. The λmax of AMH is found to be 239 nm, and the method has been validated according to the International Conference on Harmonization Q2A guidelines. The linearity of the developed method is within the range 0.5–2.5 µg/mL with the correlation coefficient (r2) of 0.9949, which indicates the higher sensitivity of the detection compared with the reported spectrophotometric methods. The percentage recovery (98–102%), precision, limit of detection (0.0266 µg/mL), and limit of quantification (0.0806 µg/mL) data also ensure the method efficiency. The forced degradation studies under the influence of various external factors also suggested the validity of the proposed method for routine analysis. The method was extended for the quantification of AMH present in marketed formulations.

амитриптилина гидрохлоридУФ-спектрофотометрический методвалидация методапринудительная деградацияamitriptyline hydrochlorideUV spectrophotometric methodmethod validationforced degradationThe authors are grateful to the Principal, JSS College of Pharmacy, Mysuru and JSS Academy of Higher Education & Research, Mysuru, for providing the facilities for the successful completion of the research work.ReferencesK. Hisaoka-Nakashima, K. Miyano, C. Matsumoto, N. Kajitani, H. Abe, M. Okada-Tsuchioka, A. Yokoyama, Y. Uezono, N. Morioka, Y. Nakata, M. Takebayashi, J. Biol. Chem., 290, 13678 (2015).K. Hisaoka-Nakashima, K. Miyano, C. Matsumoto, N. Kajitani, H. Abe, M. Okada-Tsuchioka, A. Yokoyama, Y. Uezono, N. Morioka, Y. Nakata, M. Takebayashi, J. Biol. Chem., 290, 13678 (2015).R. L. Carasso, S. Yehuda, M. Streifler, Int. J. Neurosci., 9, 191 (1979).R. L. Carasso, S. Yehuda, M. Streifler, Int. J. Neurosci., 9, 191 (1979).H. Obata, Int. J. Mol. Sci., 18, 2483 (2017).H. Obata, Int. J. Mol. Sci., 18, 2483 (2017).M. King, N. Ashraf, Drug Saf. Case Rep., 5, 1 (2018).M. King, N. Ashraf, Drug Saf. Case Rep., 5, 1 (2018).E. Fattahian, V. Hajhashemi, M. Rabbani, M. Minaiyan, P. Mahzouni, Iran. J. Pharm. Res., 15, 125 (2016).E. Fattahian, V. Hajhashemi, M. Rabbani, M. Minaiyan, P. Mahzouni, Iran. J. Pharm. Res., 15, 125 (2016).P. K. Nazarian, S. H. Park, Ment. Health Clin., 4, 41 (2014).P. K. Nazarian, S. H. Park, Ment. Health Clin., 4, 41 (2014).P. J. Wiffen, J. Pain Palliat. Care Pharmacother., 27, 179 (2013).P. J. Wiffen, J. Pain Palliat. Care Pharmacother., 27, 179 (2013).K. Lawson, Biomedicines, 5, 24 (2017).K. Lawson, Biomedicines, 5, 24 (2017).National Center for Biotechnology Information (2021). PubChem Compound Summary for CID 11065, Amitriptyline hydrochloride. Retrieved May 1, 2021, https://pubchem.ncbi.nlm.nih.gov/compound/Amitriptyline-hydrochloride.National Center for Biotechnology Information (2021). PubChem Compound Summary for CID 11065, Amitriptyline hydrochloride. Retrieved May 1, 2021, https://pubchem.ncbi.nlm.nih.gov/compound/Amitriptyline-hydrochloride.K. A. Talerico, Am. J. Nurs., 99 (1999).K. A. Talerico, Am. J. Nurs., 99 (1999).L. Hertle, A. van Ophoven, Aktuelle Urol., 41, Suppl. 1, S61 (2010).L. Hertle, A. van Ophoven, Aktuelle Urol., 41, Suppl. 1, S61 (2010).P. Soni, D. Sinha, R. Patel, J. Spectrosc., 783457 (2013).P. Soni, D. Sinha, R. Patel, J. Spectrosc., 783457 (2013).T. Aman, A. A. Kazi, M. I. Hussain, S. Firdous, I. U. Khan, Anal. Lett., 33, 2477 (2000).T. Aman, A. A. Kazi, M. I. Hussain, S. Firdous, I. U. Khan, Anal. Lett., 33, 2477 (2000).K. Susmitha, M. Thirumalachary, T. Charan Singh, G. Venkateshwarlu, J. Chil. Chem. Soc. 59, 2265 (2014).K. Susmitha, M. Thirumalachary, T. Charan Singh, G. Venkateshwarlu, J. Chil. Chem. Soc. 59, 2265 (2014).F. A. Mohamed, H. A. Mohamed, S. A. Hussein, S. A. Ahmed, J. Pharm. Biomed. Anal., 39, 139 (2005).F. A. Mohamed, H. A. Mohamed, S. A. Hussein, S. A. Ahmed, J. Pharm. Biomed. Anal., 39, 139 (2005).A. E. El-Gendy, M. G. El-Bardicyy, H. M. Loutfy, M. F. El-Tarras, Spectrosc. Lett., 26, 1649 (1993).A. E. El-Gendy, M. G. El-Bardicyy, H. M. Loutfy, M. F. El-Tarras, Spectrosc. Lett., 26, 1649 (1993).R. M. El-Nashar, N. T. Abdel Ghani, A. A. Bioumy, Microchem. J., 78, 107 (2004).R. M. El-Nashar, N. T. Abdel Ghani, A. A. Bioumy, Microchem. J., 78, 107 (2004).S. Patel, N. J. Patel, Indian J. Pharm. Sci., 71, 472 (2009).S. Patel, N. J. Patel, Indian J. Pharm. Sci., 71, 472 (2009).G. A. Smith, P. Schulz, K. M. Giacomini, T. F. Blaschke, J. Pharm. Sci., 71, 581 (1982).G. A. Smith, P. Schulz, K. M. Giacomini, T. F. Blaschke, J. Pharm. Sci., 71, 581 (1982).R. Linden, M. V. Antunes, A. L. Ziulkoski, M. Wingert, P. Tonello, M. Tzvetkov, A. A. Souto, J. Brazilian Chem. Soc., 19, 35 (2008).R. Linden, M. V. Antunes, A. L. Ziulkoski, M. Wingert, P. Tonello, M. Tzvetkov, A. A. Souto, J. Brazilian Chem. Soc., 19, 35 (2008).I. A. Naguib, N. A. Ali, F. A. Elroby, M. R. El Ghobashy, F. F. Abdallah, Bioanalysis, 12, 1521 (2020).I. A. Naguib, N. A. Ali, F. A. Elroby, M. R. El Ghobashy, F. F. Abdallah, Bioanalysis, 12, 1521 (2020).M. Blessy, R. D. Patel, P. N. Prajapati, Y. K. Agrawal, J. Pharm. Anal., 4, 159 (2014).M. Blessy, R. D. Patel, P. N. Prajapati, Y. K. Agrawal, J. Pharm. Anal., 4, 159 (2014).P. K. Porwal, N. Upmanyu, Acta Pharm. Sin. B, 4, 438 (2014).P. K. Porwal, N. Upmanyu, Acta Pharm. Sin. B, 4, 438 (2014).D. W. G. Harron, Text. Pharm. Med., 522 (2009).D. W. G. Harron, Text. Pharm. Med., 522 (2009).

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