Development and Validation of a Stability-Indicating UV Spectroscopic Method for Amisulpride in Bulk and Formulations

A straightforward, precise, reliable, and stability-indicating UV-spectrophotometer approach was created to estimate amisulpride. It utilized a Shimadzu model 1800 spectrophotometer with 0.1 N HCl as the solvent and a wave length (λmax) of 227 nm. For amisulpride, linearity was found between 10-9100 µg/ml. It was shown that the recovery percentage ranged from 95.00 to 99.6%.
The medication underwent oxidation, dry heat, UV radiation, and photolytic destruction in addition to hydrolysis by acids, alkalis, and neutrals. System appropriateness, specificity, precision, linearity, accuracy, robustness, ruggedness, LOD, and LOQ are all demonstrated by validation trials.
Excipients and other additions did not interfere with the estimation of the commercial formulation. Hence, amisulpride in bulk and its medicinal dose forms may be routinely determined using this method. The stability study approach that was suggested demonstrates that there was a noticeable deterioration in amisulpride under stress conditions.

Analytical method, validation, amisulpride, degradation, UV Spectroscopy.

1. Skoog DA, Hollar FJ, Crouch SR. An Introduction to Ultraviolet-Visible Molecular Absorption Spectrometry. In, Principles of Instrumental Analysis, 6th ed, Harayana: Thomson; 2007. p. 336-7. [Google Scholar] [Crossref]

2. Stenlake JB, Beckett AH. The Basis of Spectrophotometer. Practical pharmaceutical Chemistry, 4th edition, Part.2, New Delhi: CBS Publishers and Distributors; 2007. p. 255-7. [Google Scholar] [Crossref]

3. Syeda HUMAIRA, Spectrophotometric determination of amisulpride, Turk J. Pharm. Sci. 6 (3), 2009, p. 221-230. [Google Scholar] [Crossref]

4. K. K. Pradhan, U. S. Mishra, S. Pattnaik1, C. K. Panda and K. C. Sahu, Development and Validation of a Stability-indicating UV Spectroscopic Method for Candesartan in Bulk and Formulations, Indian Journal of Pharmaceutical Sciences, 2011, P. 693-696. [Google Scholar] [Crossref]

5. Philippe Nuss, Martina Hummer, Cédric Tessier, The use of amisulpride in the treatment of acute psychosis, Therapeutics and Clinical Risk Management 3(1), 2007: p. 3–11. [Google Scholar] [Crossref]

6. Pritam S. Jain, Amar J. Chaudhari, Stuti A. Patel, Zarana N. Patel, and Dhwani T. Patel, Development and validation of the UV-spectrophotometric method for determination of terbinafine hydrochloride in bulk and in formulation, Pharm Methods. 2(3): 2011, p. 198–202. [Google Scholar] [Crossref]

7. Piyush Gupta, Tara Chand and Manoj Khardiya, Analytical Method Development and its Validation for Estimation of Amisulpride by Reversed Phase High Performance Liquid Chromatography (RP-HPLC), International Journal of Research in Pharmaceutical and Biomedical Sciences, Vol. 4 (2), 2013 p. 542-549. [Google Scholar] [Crossref]

8. Kamal Sweidan, Mohammad Elayan, Dima Sabbah, Gada Idrees and Tawfiq Arafat, Study of Forced Degradation Behavior of Amisulpride by LC-MS and NMR and Development of a Stability-Indicating Method, Bentham science, Volume 14, Issue 2, 2018 p. 157-165. [Google Scholar] [Crossref]

9. Anna Maślanka, Pawel Żmudzki, Marek Szlósarczyk, Przemysław Talik,Urszula Hubicka, Photodegradation assessment of amisulpride, doxepin, haloperidol, risperidone, venlafaxine, and zopiclone in bulk drug and in the presence of excipients, Monatshefte für Chemie – 151, 2020,p. 483–493. [Google Scholar] [Crossref]

10. Budavari S. The Merck Index. 12th ed. New Jersey, USA: Merck and Co., Inc; 1996. p. 1564. [Google Scholar] [Crossref]

11. Martindale. The Complete Drug Reference. 32nd ed. Great Britain: Council of Royal Pharmaceutical Society of Great Britain; 1999. pp. 367–87. [Google Scholar] [Crossref]

12. Delgodo JN, Remers WA. Text book of Organic Medicinal and Pharmaceutical Chemistry. 9th ed. Philadelphia: J. B. Liipincott Company; 1991. Wilson and Gisvold's; pp. 145–53. [Google Scholar] [Crossref]

13. Gonecalves-codoso S, Schapoval EE. High performance chromatographic assay of terbinafine hydrochloride in tablets and creams. J Pharm Biomed Anal. 1999;19:809–12. doi: 10.1016/s0731-7085(98)00119-8. [Google Scholar] [Crossref]

14. Ji XF, Yu KY, Zhang W. Determination of terbinafine hydrochloride, chlorohexidine and triameinolone acetonide acetate in compound ointment by reversed phase HPLC. Chin J Pharm Anal. 1997;17:363–5. [Google Scholar] [Crossref]

15. Yagnesh MH, Melachlan AJ. Determination of terbinafine in tissues. Biomed Chromatogr. 2000;14:261–8. [Google Scholar] [Crossref]

16. Zehender H, Denouel J, Roy M, Le-Saux L, Schuab P. Simultaneous determination of terbinafine and five metabolites in human plasma and urine by high performance liquid chromatography using online solid phase extraction. J Chromatogr B. 1995;664:347–55. [Google Scholar] [Crossref]

17. Denouel J, Keller HP, Schaub P, Delborde C, Humbert H. Determination of terbinafine and its desmethyl metabolites in human plasma by high performance liquid chromatography. J Chromatogr B. 1995;663:353–9. [Google Scholar] [Crossref]

18. f.Schatz F, Haberl H. Analytical methods for the determination of terbinafine and its metabolites in human plasma, milk and urine. Arzneim-Forsch. 1989;39:527–32. [Google Scholar] [Crossref]

19. Brigol N, Bakhtiyar R, Dou L, Majumdar T, Tse FL. Quantitative analysis of terbinafine in human and minipig plasma by liquid chromatography tandem mass spectrometry. Rapid Commun Mass-Spctrom. 2000;14:141–9. [Google Scholar] [Crossref]

20. Cardoso SG, Schapoval EE. UV spectrophotometry and non aqueous determination of terbinafine hydrochloride in dosage forms. J AOAC Int. 1999;82:380–3. [Google Scholar] [Crossref]

21. Arranz A, Fernandez S, Moreda JM, Cid A, Arranz JF. Voltametric behavior of the antimycotic terbinafine at the hanging mercury drop electrode. Anal Chim Acta. 1997;351:97–103. [Google Scholar] [Crossref]

22. Arun Prasad K, Narayanan N, Rajalakshami G. Preparation and evaluation of solid dispersion of terbinafine hydrochloride. Int J Pharm Sci Rev Res. 2010;3:130–4. [Google Scholar] [Crossref]

23. ICH-Guidelines Q2 (R1), Validation of Analytical Procedures: Text and Methodology. 2005 [Google Scholar] [Crossref]

• Development and Evaluation of Floating Alginate Beads of Esomeprazole
• Determination of pKa Value for Ranolazine and Atenolol Using UV Spectroscopy
• The Science of Sustained-Release Medications
• Development of Proteomics in Clinical Medicine
• Advances on Quinoline Derivatives: A Review of Synthesis and Biological Activities