zhpsЖурнал прикладной спектроскопииZhurnal Prikladnoii Spektroskopii0514-7506B. I. Stepanov Institute of Physics of the National Academy of Scienceszhps-951Research ArticleСтатьиРазработка и валидация спектрофотометрического метода на основе первой производной для оценки антипсихотического компонента в фармацевтических препаратах и исследованиях принудительной деградацииDevelopment and validation of a first-derivative spectrophotometric method for the estimation of an antipsychotic drug in pharmaceutical formulations and forced degradation studiesDashS. K.DashS. K.

Берхампур 760010, Одиша

Berhampur 760010, Odisha

AcharjyaS. K.AcharjyaS. K.

Берхампур 760010, Одиша

Berhampur 760010, Odisha

acharjya2009@gmail.comDasP. S.DasP. S.

Берхампур 760010, Одиша

Berhampur 760010, Odisha

KumarN. K.KumarN. K.

Берхампур 760010, Одиша

Berhampur 760010, Odisha

PatraCh. N.PatraCh. N.

Берхампур 760010, Одиша

Berhampur 760010, Odisha

Институт фармацевтических наук РоландаRoland Institute of Pharmaceutical Sciences, Department of Pharmaceutical Analysis and Quality Assurance202130112021886975975Copyright © Dash S.K., Acharjya S.K., Das P.S., Kumar N.K., Patra C.N., 20212021Dash S.K., Acharjya S.K., Das P.S., Kumar N.K., Patra C.N.Dash S.K., Acharjya S.K., Das P.S., Kumar N.K., Patra C.N.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/951

Разработан спектрофотометрический метод на основе первой производной для количественного определения палиперидона в различных фармацевтических препаратах. В данном методе препарат показывает максимум dA/dλ при 245 нм, что соответствует закону Бера–Ламберта в диапазоне концентраций 2.5–70.0 мкг/мл. Исследованы кислотный гидролиз, щелочной гидролиз, термическое, окислительное и фотолитическое разложения лекарственного средства. Получены результаты в допустимых пределах. Параметры валидации аналитического метода (линейность, LOD, LOQ, прецизионность, точность и т. д.) определены в соответствии с рекомендациями ICH Q2R (1) и находятся в пределах допустимого диапазона. 

A simple, cost-effective, and stability-indicating first-derivative spectrophotometric technique for quantifying Paliperidone in different pharmaceutical formulations is developed. In this method, the drug shows a maximum dA/dλ at 245 nm. The drug follows Beer–Lambert’s law in the concentration range 2.5–70 µg/mL. Various degradation studies for the drug, such as acid hydrolysis, base hydrolysis, thermal, oxidative, and photolytic degradation are performed, and the results thereof are within the acceptable limit. The analytical method validation parameters like linearity, LOD, LOQ, precision, accuracy, etc. are conducted for the method as per the ICH Q2R(1) guideline, and the values are within the allowable range. Hence, for the determination of the Paliperidone quantity in pharmaceutical dosage forms, the developed process is a feasible one. 

палиперидонспектрофотометрия на основе производнойпринудительная деградацияpaliperidonederivative spectroscopyforced degradationThe authors are thankful to the Roland Institute of Pharmaceutical Sciences, Berhampur-10, Odisha, India, for providing the research facilities.ReferencesS. D. Sawant, V. U. Barge, J. Pharm. Res., 6, No. 1, 39–47 (2013).S. D. Sawant, V. U. Barge, J. Pharm. Res., 6, No. 1, 39–47 (2013).B. M. Firake, H. P. Bhutada, R. S. Talekar, D. A. Korde, ACAIJ, 16, No. 7, 277–287 (2016).B. M. Firake, H. P. Bhutada, R. S. Talekar, D. A. Korde, ACAIJ, 16, No. 7, 277–287 (2016).D. Bishara, Neuropsych Dis. Treat., 6, 561–572 (2010).D. Bishara, Neuropsych Dis. Treat., 6, 561–572 (2010).H. A. Richard, C. C. Pamela, Lippincott Illustrated Reviews: Pharmacology, Neuroleptics, 4th ed., Wolters Kluwer (India) Pvt. Ltd., New Delhi, 156 (2009).H. A. Richard, C. C. Pamela, Lippincott Illustrated Reviews: Pharmacology, Neuroleptics, 4th ed., Wolters Kluwer (India) Pvt. Ltd., New Delhi, 156 (2009).R. S. Satoskar, N. N. Rege, S. D. Bhandarkar, Pharmacology and Pharmacotherapeutics, Psychopharmacology, 23rd ed., Popular Prakashan, Mumbai, 202 (2013).R. S. Satoskar, N. N. Rege, S. D. Bhandarkar, Pharmacology and Pharmacotherapeutics, Psychopharmacology, 23rd ed., Popular Prakashan, Mumbai, 202 (2013).S. M. Hoy, L. J. Scott, G. M. Keating, Sci. World J., 24, No. 3, 227–244 (2010).S. M. Hoy, L. J. Scott, G. M. Keating, Sci. World J., 24, No. 3, 227–244 (2010).L. Citrome, Int. J. Clin. Practice, 64, No. 2, 216–239 (2010).L. Citrome, Int. J. Clin. Practice, 64, No. 2, 216–239 (2010).R. K. Trivedi. R. Jupudi, M. C. Patel, D. R. Trivedi, H. A. Jogia, Res. Rev. J. Pharm. Pharm. Sci., 2, 37–41 (2013).R. K. Trivedi. R. Jupudi, M. C. Patel, D. R. Trivedi, H. A. Jogia, Res. Rev. J. Pharm. Pharm. Sci., 2, 37–41 (2013).D. Injavarapu, U. P. Panigrahi, Int. J. Pharm. Res. BioSci., 3, No. 2, 106–125 (2014).D. Injavarapu, U. P. Panigrahi, Int. J. Pharm. Res. BioSci., 3, No. 2, 106–125 (2014).V. V. Nishath, B. M. Gurupadayaa, Int. J. Eng. Res. Technol., 8, No. 12, 120–139 (2019).V. V. Nishath, B. M. Gurupadayaa, Int. J. Eng. Res. Technol., 8, No. 12, 120–139 (2019).U. Korrapati, R. Chintala, Chem. Sci. Trans., 3, No. 3, 1156–1162 (2014).U. Korrapati, R. Chintala, Chem. Sci. Trans., 3, No. 3, 1156–1162 (2014).S. S. Panda, J. Rath, V. V. R. K. Bera, Anal. Chem. Lett., 8, No. 4, 510–518 (2018).S. S. Panda, J. Rath, V. V. R. K. Bera, Anal. Chem. Lett., 8, No. 4, 510–518 (2018).S. A. Jadav, S. B. Landge, P. M. Choudhari, P. V. Solanki, S. R. Bembalkar, V. T. Mathad, Chromatogr. Res. Int., 2011, 1–10 (2011).S. A. Jadav, S. B. Landge, P. M. Choudhari, P. V. Solanki, S. R. Bembalkar, V. T. Mathad, Chromatogr. Res. Int., 2011, 1–10 (2011).K. Dadare, N. C. Khatri, P. Mayank, J. Chem. Pharm. Res., 4, No. 6, 3154–3157 (2012).K. Dadare, N. C. Khatri, P. Mayank, J. Chem. Pharm. Res., 4, No. 6, 3154–3157 (2012).A. S. Manjula, T. K. Ravi, Am. J. Pharm. Tech. Res., 2, No. 3, 616–626 (2012).A. S. Manjula, T. K. Ravi, Am. J. Pharm. Tech. Res., 2, No. 3, 616–626 (2012).M. Farooqui, R. Z. Ahmed, J. N. Sangshetti, Z. Zaheer, A. Wahab, M. Deshpande, S. Bhojane, S. R. Baig, Indo Am. J. Pharm. Res., 3, 3175–1383 (2013).M. Farooqui, R. Z. Ahmed, J. N. Sangshetti, Z. Zaheer, A. Wahab, M. Deshpande, S. Bhojane, S. R. Baig, Indo Am. J. Pharm. Res., 3, 3175–1383 (2013).S. Kancharla, G. S. Pavan, N. D. Paladugu, S. Bonthu, D. Poloju, Int. J. Biol. Pharm. Res., 4, 412–416 (2013).S. Kancharla, G. S. Pavan, N. D. Paladugu, S. Bonthu, D. Poloju, Int. J. Biol. Pharm. Res., 4, 412–416 (2013).K. Umamahesswar, G. Ramu, C. Rambabu, Chem. Sci. Trans., 2, No. 1, 41–46 (2013).K. Umamahesswar, G. Ramu, C. Rambabu, Chem. Sci. Trans., 2, No. 1, 41–46 (2013).K. N. Rao, S. Ganapathy, A. L. Rao, Rasayan. J. Chem., 6, No. 1, 34–38 (2013).K. N. Rao, S. Ganapathy, A. L. Rao, Rasayan. J. Chem., 6, No. 1, 34–38 (2013).H. Boga, A. Patnaik, Int. J. Innov. Pharm. Sci. Res., 2, No. 11, 2709–2718 (2014).H. Boga, A. Patnaik, Int. J. Innov. Pharm. Sci. Res., 2, No. 11, 2709–2718 (2014).S. Rudragangaiah, R. G. Bhatt, S. B. B. Kotappa, Indian J. Pharm. Educ. Res., 53, No. 4, 691–698 (2019).S. Rudragangaiah, R. G. Bhatt, S. B. B. Kotappa, Indian J. Pharm. Educ. Res., 53, No. 4, 691–698 (2019).K. H. Bindu, I. U. Reddy, Y. Anjaneyelu, M. V. Suryanarayana, J. Chrom. Sci., 50, No. 4, 368–372 (2012).K. H. Bindu, I. U. Reddy, Y. Anjaneyelu, M. V. Suryanarayana, J. Chrom. Sci., 50, No. 4, 368–372 (2012).K. H. Bindu, N. H. Dhekale, M. V. Suryanarayana, Y. Anjaneyuly, J. Chromatogr. Relat. Technol., 35, No. 4, 533–546 (2012).K. H. Bindu, N. H. Dhekale, M. V. Suryanarayana, Y. Anjaneyuly, J. Chromatogr. Relat. Technol., 35, No. 4, 533–546 (2012).R. K. Trivedi, P. Jain, M. C. Patel, P. M. Chatrabhji, D. R. Trivedi, J. Appl. Pharm. Sci., 3, No. 7, 87–92 (2013).R. K. Trivedi, P. Jain, M. C. Patel, P. M. Chatrabhji, D. R. Trivedi, J. Appl. Pharm. Sci., 3, No. 7, 87–92 (2013).R. B. Patel, M. R. Patel, K. K. Bhatt, B. G. Patel, Anal. Methods, 2, 525–531 (2010).R. B. Patel, M. R. Patel, K. K. Bhatt, B. G. Patel, Anal. Methods, 2, 525–531 (2010).S. M. Pawar, S. R. Dhaneswar, J. Pharm. Biomed. Sci., 16, No. 15, 1–5 (2012).S. M. Pawar, S. R. Dhaneswar, J. Pharm. Biomed. Sci., 16, No. 15, 1–5 (2012).M. Z. Bocato, R. A. Simoes, L. A. Calixto, C. M. de Gaitani, M. T. Pupo, A. R. de Oliveria, Anal. Chim. Acta, 742, 80–89 (2012).M. Z. Bocato, R. A. Simoes, L. A. Calixto, C. M. de Gaitani, M. T. Pupo, A. R. de Oliveria, Anal. Chim. Acta, 742, 80–89 (2012).H. Chen, L. Zhao, G. Li, D. Leng, P. Ma, L.Tong, T. Zhang, Asian J. Pharm. Sci., 9, 286–292 (2014).H. Chen, L. Zhao, G. Li, D. Leng, P. Ma, L.Tong, T. Zhang, Asian J. Pharm. Sci., 9, 286–292 (2014).Md. S. Uddin, A. A. Mamun, T. Tasnu, Md. Asaduzaaman, J. Chem. Pharm. Res., 7, No. 9, 180–185 (2015).Md. S. Uddin, A. A. Mamun, T. Tasnu, Md. Asaduzaaman, J. Chem. Pharm. Res., 7, No. 9, 180–185 (2015).J. Patel, G. Kevin, A. Patel. M. Raval, N. Sheth, Pharm. Method., 2, No. 1, 36–41 (2011).J. Patel, G. Kevin, A. Patel. M. Raval, N. Sheth, Pharm. Method., 2, No. 1, 36–41 (2011).Saranjit Singh, Sanjay Garg, Pharma Times, August 99, 15–20 (1999).Saranjit Singh, Sanjay Garg, Pharma Times, August 99, 15–20 (1999).S. Aashigari, G. G. Ramya, S. Sneha, U. Vykuntam, N. R. Potnuri, World J. Pharm. Res., 8, No. 1, 479–492 (2019).S. Aashigari, G. G. Ramya, S. Sneha, U. Vykuntam, N. R. Potnuri, World J. Pharm. Res., 8, No. 1, 479–492 (2019).S. Singh, B. Monika, Guidance on Conduct of Stress Tests to Determine Inherent Stability of Drugs, 24–36 (2000); https://www.semanticscholar.org/paper/Guidance-on-Conduct-of-Stress-Tests-to-Determineof-Singh-Bakshi/fce4347f5ddbc12ac1f74d9f7e7ae6db3be2336b.S. Singh, B. Monika, Guidance on Conduct of Stress Tests to Determine Inherent Stability of Drugs, 24–36 (2000); https://www.semanticscholar.org/paper/Guidance-on-Conduct-of-Stress-Tests-to-Determineof-Singh-Bakshi/fce4347f5ddbc12ac1f74d9f7e7ae6db3be2336b.S. Shing, Stability testing during product development in Jain NK Pharmaceutical product development. CBS publisher and distributors, India, 272–293 (2006).S. Shing, Stability testing during product development in Jain NK Pharmaceutical product development. CBS publisher and distributors, India, 272–293 (2006).ICH Q1A (R2): Stability Testing of New Drug Substances and Products, Current Step 4 dated February (2003); http://www.ich.org/fileadmin/public_Web_Site/ICH-Products/Guidelines/Quality/Q1A-R2/Step4/Q1A-R2_Guideline pdf.ICH Q1A (R2): Stability Testing of New Drug Substances and Products, Current Step 4 dated February (2003); http://www.ich.org/fileadmin/public_Web_Site/ICH-Products/Guidelines/Quality/Q1A-R2/Step4/Q1A-R2_Guideline pdf.WHO Technical Report Series, No. 929, 2005, Annex 5, Guidelines for Registration of Fixed-Dose Combination Medicinal Products, Appendix 3, Pharmaceutical Development (or Preformulation) Studies.WHO Technical Report Series, No. 929, 2005, Annex 5, Guidelines for Registration of Fixed-Dose Combination Medicinal Products, Appendix 3, Pharmaceutical Development (or Preformulation) Studies.

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