|Generate QR code
Open Access
Subscription Access
Development and validation of a first-derivative spectrophotometric method for the estimation of an antipsychotic drug in pharmaceutical formulations and forced degradation studies
Abstract
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.
Supporting agencies: The authors are thankful to the Roland Institute of Pharmaceutical Sciences, Berhampur-10, Odisha, India, for providing the research facilities.
About the Authors
S. K. Dash
Roland Institute of Pharmaceutical Sciences, Department of Pharmaceutical Analysis and Quality Assurance
India
India
Berhampur 760010, Odisha
S. K. Acharjya
Roland Institute of Pharmaceutical Sciences, Department of Pharmaceutical Analysis and Quality Assurance
India
India
Berhampur 760010, Odisha
P. S. Das
Roland Institute of Pharmaceutical Sciences, Department of Pharmaceutical Analysis and Quality Assurance
India
India
Berhampur 760010, Odisha
N. K. Kumar
Roland Institute of Pharmaceutical Sciences, Department of Pharmaceutical Analysis and Quality Assurance
India
India
Berhampur 760010, Odisha
Ch. N. Patra
Roland Institute of Pharmaceutical Sciences, Department of Pharmaceutical Analysis and Quality Assurance
India
India
Berhampur 760010, Odisha
References
1. S. D. Sawant, V. U. Barge, J. Pharm. Res., 6, No. 1, 39–47 (2013).
2. B. M. Firake, H. P. Bhutada, R. S. Talekar, D. A. Korde, ACAIJ, 16, No. 7, 277–287 (2016).
3. D. Bishara, Neuropsych Dis. Treat., 6, 561–572 (2010).
4. H. A. Richard, C. C. Pamela, Lippincott Illustrated Reviews: Pharmacology, Neuroleptics, 4th ed., Wolters Kluwer (India) Pvt. Ltd., New Delhi, 156 (2009).
5. R. S. Satoskar, N. N. Rege, S. D. Bhandarkar, Pharmacology and Pharmacotherapeutics, Psychopharmacology, 23rd ed., Popular Prakashan, Mumbai, 202 (2013).
6. S. M. Hoy, L. J. Scott, G. M. Keating, Sci. World J., 24, No. 3, 227–244 (2010).
7. L. Citrome, Int. J. Clin. Practice, 64, No. 2, 216–239 (2010).
8. R. K. Trivedi. R. Jupudi, M. C. Patel, D. R. Trivedi, H. A. Jogia, Res. Rev. J. Pharm. Pharm. Sci., 2, 37–41 (2013).
9. D. Injavarapu, U. P. Panigrahi, Int. J. Pharm. Res. BioSci., 3, No. 2, 106–125 (2014).
10. V. V. Nishath, B. M. Gurupadayaa, Int. J. Eng. Res. Technol., 8, No. 12, 120–139 (2019).
11. U. Korrapati, R. Chintala, Chem. Sci. Trans., 3, No. 3, 1156–1162 (2014).
12. S. S. Panda, J. Rath, V. V. R. K. Bera, Anal. Chem. Lett., 8, No. 4, 510–518 (2018).
13. 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).
14. K. Dadare, N. C. Khatri, P. Mayank, J. Chem. Pharm. Res., 4, No. 6, 3154–3157 (2012).
15. A. S. Manjula, T. K. Ravi, Am. J. Pharm. Tech. Res., 2, No. 3, 616–626 (2012).
16. 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).
17. S. Kancharla, G. S. Pavan, N. D. Paladugu, S. Bonthu, D. Poloju, Int. J. Biol. Pharm. Res., 4, 412–416 (2013).
18. K. Umamahesswar, G. Ramu, C. Rambabu, Chem. Sci. Trans., 2, No. 1, 41–46 (2013).
19. K. N. Rao, S. Ganapathy, A. L. Rao, Rasayan. J. Chem., 6, No. 1, 34–38 (2013).
20. H. Boga, A. Patnaik, Int. J. Innov. Pharm. Sci. Res., 2, No. 11, 2709–2718 (2014).
21. S. Rudragangaiah, R. G. Bhatt, S. B. B. Kotappa, Indian J. Pharm. Educ. Res., 53, No. 4, 691–698 (2019).
22. K. H. Bindu, I. U. Reddy, Y. Anjaneyelu, M. V. Suryanarayana, J. Chrom. Sci., 50, No. 4, 368–372 (2012).
23. K. H. Bindu, N. H. Dhekale, M. V. Suryanarayana, Y. Anjaneyuly, J. Chromatogr. Relat. Technol., 35, No. 4, 533–546 (2012).
24. R. K. Trivedi, P. Jain, M. C. Patel, P. M. Chatrabhji, D. R. Trivedi, J. Appl. Pharm. Sci., 3, No. 7, 87–92 (2013).
25. R. B. Patel, M. R. Patel, K. K. Bhatt, B. G. Patel, Anal. Methods, 2, 525–531 (2010).
26. S. M. Pawar, S. R. Dhaneswar, J. Pharm. Biomed. Sci., 16, No. 15, 1–5 (2012).
27. 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).
28. H. Chen, L. Zhao, G. Li, D. Leng, P. Ma, L.Tong, T. Zhang, Asian J. Pharm. Sci., 9, 286–292 (2014).
29. Md. S. Uddin, A. A. Mamun, T. Tasnu, Md. Asaduzaaman, J. Chem. Pharm. Res., 7, No. 9, 180–185 (2015).
30. J. Patel, G. Kevin, A. Patel. M. Raval, N. Sheth, Pharm. Method., 2, No. 1, 36–41 (2011).
31. Saranjit Singh, Sanjay Garg, Pharma Times, August 99, 15–20 (1999).
32. S. Aashigari, G. G. Ramya, S. Sneha, U. Vykuntam, N. R. Potnuri, World J. Pharm. Res., 8, No. 1, 479–492 (2019).
33. 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.
34. S. Shing, Stability testing during product development in Jain NK Pharmaceutical product development. CBS publisher and distributors, India, 272–293 (2006).
35. 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.
36. 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.
Review
For citations:
Dash S.K., Acharjya S.K., Das P.S., Kumar N.K., Patra Ch.N. Development and validation of a first-derivative spectrophotometric method for the estimation of an antipsychotic drug in pharmaceutical formulations and forced degradation studies. Zhurnal Prikladnoii Spektroskopii. 2021;88(6):975.
Views: 206
Email this article 