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.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
S. D. Sawant and V. U. Barge, J. Pharm. Res., 6, No. 1, 39–47 (2013).
B. M. Firake, H. P. Bhutada, R. S. Talekar, and D. A. Korde, ACAIJ, 16, No. 7, 277–287 (2016).
D. Bishara, Neuropsych Dis. Treat., 6, 561–572 (2010).
H. A. Richard and 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, and S. D. Bhandarkar, Pharmacology and Pharmacotherapeutics, Psychopharmacology, 23rd ed., Popular Prakashan, Mumbai, 202 (2013).
S. M. Hoy, L. J. Scott, and G. M. Keating, Sci. World J., 24, No. 3, 227–244 (2010).
L. Citrome, Int. J. Clin. Practice, 64, No. 2, 216–239 (2010).
R. K. Trivedi. R. Jupudi, M. C. Patel, D. R. Trivedi, and H. A. Jogia, Res. Rev. J. Pharm. Pharm. Sci., 2, 37–41 (2013).
D. Injavarapu and U. P. Panigrahi, Int. J. Pharm. Res. BioSci., 3, No. 2, 106–125 (2014).
V. V. Nishath and B. M. Gurupadayaa, Int. J. Eng. Res. Technol., 8, No. 12, 120–139 (2019).
U. Korrapati and R. Chintala, Chem. Sci. Trans., 3, No. 3, 1156–1162 (2014).
S. S. Panda, J. Rath, and 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, and V. T. Mathad, Chromatogr. Res. Int., 2011, 1–10 (2011).
K. Dadare, N. C. Khatri, and P. Mayank, J. Chem. Pharm. Res., 4, No. 6, 3154–3157 (2012).
A. S. Manjula and 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, and S. R. Baig, Indo Am. J. Pharm. Res., 3, 3175–1383 (2013).
S. Kancharla, G. S. Pavan, N. D. Paladugu, S. Bonthu, and D. Poloju, Int. J. Biol. Pharm. Res., 4, 412–416 (2013).
K. Umamahesswar, G. Ramu, and C. Rambabu, Chem. Sci. Trans., 2, No. 1, 41–46 (2013).
K. N. Rao, S. Ganapathy, and A. L. Rao, Rasayan. J. Chem., 6, No. 1, 34–38 (2013).
H. Boga and A. Patnaik, Int. J. Innov. Pharm. Sci. Res., 2, No. 11, 2709–2718 (2014).
S. Rudragangaiah, R. G. Bhatt, and S. B. B. Kotappa, Indian J. Pharm. Educ. Res., 53, No. 4, 691–698 (2019).
K. H. Bindu, I. U. Reddy, Y. Anjaneyelu, and M. V. Suryanarayana, J. Chrom. Sci., 50, No. 4, 368–372 (2012).
K. H. Bindu, N. H. Dhekale, M. V. Suryanarayana, and Y. Anjaneyuly, J. Chromatogr. Relat. Technol., 35, No. 4, 533–546 (2012).
R. K. Trivedi, P. Jain, M. C. Patel, P. M. Chatrabhji, and D. R. Trivedi, J. Appl. Pharm. Sci., 3, No. 7, 87–92 (2013).
R. B. Patel, M. R. Patel, K. K. Bhatt, and B. G. Patel, Anal. Methods, 2, 525–531 (2010).
S. M. Pawara and 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, and A. R. de Oliveria, Anal. Chim. Acta, 742, 80–89 (2012).
H. Chen, L. Zhao, G. Li, D. Leng, P. Ma, L. Tong, and T. Zhang, Asian J. Pharm. Sci., 9, 286–292 (2014).
Md. S. Uddin, A. A. Mamun, T. Tasnu, and Md. Asaduzaaman, J. Chem. Pharm. Res., 7, No. 9, 180–185 (2015).
J. Patel, G. Kevin, A. Patel. M. Raval, and N. Sheth, Pharm. Method., 2, No. 1, 36–41 (2011).
Saranjit Singh and Sanjay Garg, Pharma Times, August 99, 15–20 (1999).
S. Aashigari, G. G. Ramya, S. Sneha, U. Vykuntam, and 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-Determine-of-Singh-Bakshi/fce4347f5ddbc12ac1f74d9f7e7ae6db3be2336b.
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.
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.
Author information
Authors and Affiliations
Corresponding author
Additional information
Abstract of article is published in Zhurnal Prikladnoi Spektroskopii, Vol. 88, No. 6, p. 975, November–December, 2021.
Rights and permissions
About this article
Cite this article
Dash, S.K., Acharjya, S.K., Das, P.S. et al. Development and Validation of a First-Derivative Spectrophotometric Method for the Estimation of an Antipsychotic Drug in Pharmaceutical Formulations and Forced Degradation Studies. J Appl Spectrosc 88, 1276–1283 (2022). https://doi.org/10.1007/s10812-022-01309-5
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10812-022-01309-5