DEVELOPMENT AND VALIDATION OF NEW SPECTROPHOTOMETRIC METHODS FOR ESTIMATION OF ANTIPSYCHOTIC DRUG ASENAPINE MALEATE IN PURE AND DOSAGE FORMS

  • RAGAA EL-SHEIKH Department of Chemistry, Faculty of Science, Zagazig University, Zagazig, 44519, Egypt
  • AHLAM E. ABD ELLATEIF Department of Chemistry, Toxicology and Nutritional Deficiency, Agriculture Research Center, Animal Health Research Institute, Zagazig, Egypt
  • ESRAA AKMAL Department of Chemistry, Faculty of Science, Zagazig University, Zagazig, 44519, Egypt
  • AYMAN A. GOUDA Department of Chemistry, Faculty of Science, Zagazig University, Zagazig, 44519, Egypt, Department of Occupational Health, Faculty of Public Health and Health Informatics, Umm AL-Qura University, Makkah, Saudi Arabia

Abstract

Objective: Three sensitive, simple, precise, reproducible, and validated spectrophotometric methods have been developed for the determination of anti-psychotic drug (asenapine maleate) in pure and pharmaceutical dosage forms.


Methods: The methods are based on the formation of yellow-colored ion-pair complex between asenapine maleate and three acid dyes, namely, bromocresol purple (BCP), bromophenol blue (BPB) and bromothymol blue (BTB) with absorption maxima at 410, 414 and 416 nm, respectively. Several parameters such as pH, buffer type and volume, reagent volume, the sequence of addition and effect of extracting solvent were optimized.


Results: Under the optimum experimental conditions, beer’s law is obeyed over the concentration ranges of 1.0–20, 1.0–14, and 1.0-16 μg/ml for BCP, BPB and BTB, respectively, with good correlation coefficients (0.9994-0.9998). The apparent molar absorptivity and Sandell’s sensitivity values are reported for all methods. The limit of detection (LOD) and the limit of quantification (LOQ) values are found to be 0.27, 0.30, and 0.25 μg/ml and 0.90, 1.0, and 0.83 μg/ml for BCP, BPB and BTB, respectively. The stoichiometric ratio of the formed ion-pair complexes was found to be 1:1 (drug: reagent) for all methods, as deduced by Job's method of continuous variation.


Conclusion: The proposed methods were successfully applied for the determination of asenapine maleate in pharmaceutical formulations with good accuracy and precision. Statistical comparison of the results was performed using Student's t-test and variance ratio F-test at the 95% confidence level and there was no significant difference between the reported and proposed methods regarding accuracy and precision. Further, the validity of the proposed methods was confirmed by recovery studies via standard addition technique in accordance with ICH guidelines.

Keywords: Asenapine maleate, Ion-pair complex, Spectrophotometry, Method validation, Dosage forms

References

1. Saphris (asenapine) sublingual tablets, FDA drug approval package. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022117s000_ChemR.pdf [Last accessed on 11 Feb 2016]
2. Balaraman R, Gandhi H. Asenapine, a new sublingual atypical antipsychotic. J Pharmacol Pharmacother 2010;1:60-1.
3. Ramadan NK, Mohamed TA, Fouad RM, Moustafa AA. Development and validation of stability-indicating spectrophotometric and spectrofluorimetric methods for the determination of asenapine maleate. Der Pharma Chem 2018;10:122-34.
4. Nagarajan G, Shirisha K, Archana Mu, Sravanthi P, Ramana BV. Method development and validation of RP-HPLC method for the determination of new antipsychotic agent asenapine maleate in bulk and in pharmaceutical formulation. Pharm Lett 2012;4:1805-10.
5. Chander P, Mehta T. HPLC-UV method for the determination of asenapine maleate impurities using a solid core C8 column. Thermo Fisher Sci Inc Appl Note 2013;20:739-44.
6. Aarelly K, Thimmaraju MK, Nerella R, Allabotharam S. Method development and validation of asenapine in bulk by RP-HPLC method. J Chem Pharm Res 2012;4:2580-4.
7. Parthasarathi TR, Srinivas TS, Vanitha SMS, Ram S, Basha MM, Rajesh P. Quantitative determination of asenapine maleate using reversed phase-high performance liquid chromatography. Int J Pharma Bio Sci 2012;3:360-6.
8. Geetharam Y, Ramamohan GV, Srikumar PP, Rusyendra GV, Lavanya N. Development and validation of RP-HPLC method for the estimation of asenapine maleate in bulk and pharmaceutical dosage forms. Asian J Pharm Anal Med Chem 2013;1:132-9.
9. De Boer T, Meulman E, Meijering H, Wieling J, Dogterom P, Lass H. Quantification of asenapine and three metabolites in human plasma using liquid chromatography-tandem mass spectrometry with automated solid?phase extraction: application to a phase I clinical trial with asenapine in healthy male subjects. Biomed Chromatogr 2012;26:156-65.
10. De Boer T, Meulman E, Meijering H, Wieling J, Dogterom P, Lass H. Development and validation of automated SPE-HPLC-MS/MS method for the quantification of asenapine, a new antipsychotic agent, and its two major metabolites in human urine. Biomed Chromatogr 2012;26:1461–3.
11. Govindarajan NR, Koulagari S, Methuku A, Podhuturi S. Method development and validation of RP-HPLC method for determination of new antipsychotic agent asenapine maleate in bulk and pharmaceutical formulation. Eurasian J Anal Chem 2014;9:58–65.
12. Patel NP, Sanyal M, Sharma N, Patel DS, Shrivastav PS, Patel BN. Determination of asenapine in the presence of its inactive metabolites in human plasma by LC-MS/MS. J Pharm Anal 2018;8:341–7.
13. Borkar AA, Gaikwad NJ. UV Spectrophotometric and RP-HPLC estimation of drug asenapine in tablet dosage form. Int J Pharm Sci Res 2016;7:3080-4.
14. Aneesh TP, Rajasekaran A. Stress degradation studies and development and validation of RP-HPLC method for the estimation of asenapine maleate. Int J Pharm Pharm Sci 2012;4:448-51.
15. Yadav BK, Sathish NK, Lamichhane M, Acharya A. A newer RP-UFLC method development and validation of an anti-psychotic drug asenapine maleate in bulk drug and pharmaceutical formulation. Pharm Lett 2015;7:214-9.
16. Chhalotiya UK, Bhatt KK, Shah DS, Patel JR. Stability-indicating liquid chromatographic method for the quantification of the new antipsychotic agent asenapine in bulk and in pharmaceutical formulation. Sci Pharm 2012;80:407-17.
17. Karaca SA, Ugur DY. A stability indicating ion-pair LC method for the determination of asenapine in pharmaceuticals. J Chil Chem Soc 2017;62:3325-9.
18. Shyamala, Swarupa A, Anitha P. Validated stability-indicating RP-HPLC method for determination of asenapine. Indo Am J Pharm Sci 2018;5;4107-13.
19. Kalpana GL, Devalarao G, Raju MB, Praveenkumar T. Validated stability indicating high performance liquid chromatographic method for the quantification of asenapine. Int J Pharm Pharm Sci 2015;7:61-5.
20. Narke R, Mandlik S, Kapure S. Bioanalytical development and validation of Stability indicating RP-HPLC method for the estimation of asenapine maleate in plasma. Inventi Impact Biomed Anal 2015;1:5-8.
21. Ramadan NK, Mohamed TA, Fouad RM, Moustafa AA. Stability-indicating high-performance liquid chromatography and thin-layer chromatography methods for the determination of cyclobenzaprine hydrochloride and asenapine maleate. J Plannar Chromat 2017;30:313-22.
22. Avasarala H, Jayanthi VR, Dinakaran SK. Fast and sensitive quantification of asenapine maleate by high-performance thin layer chromatography. Lat Am J Pharm 2018;37:330-3.
23. Caitlin M, Oscar P, Dan A, Diane MM, Norman WJ. Asenapine (Saphrisw): GC-MS method validation and the postmortem distribution of a new atypical antipsychotic medication. J Anal Toxicol 2013;37:559-64.
24. Ramadan NK, Mohamed TA, Fouad RM, Moustafa AA. Potentiometric determination of asenapine maleate using PVC membrane and carbon paste ion-selective electrodes. Organic Med Chem Int J 2018;8:555726.
25. Aarelly K, Thimmaraju MK, Nerella R. Quantitative determination of asenapine in both bulk and formulations using neutralization titrations. J Appl Pharm Sci 2012;2:141-5.
26. Avasarala H, Jayanthi VR. The development and validation of a spectrophotometric method for a novel anti-psychotic drug asenapine maleate. Int J ChemTech Res 2015;8:549-53.
27. Gandhimathi R, Vijayaraj S, Jyothirmaie MP. Method development and validation of UV-spectroscopic method for estimation of asenapine maleate in bulk and tablet formulation. Int J Med Chem Anal 2012;2:85-90.
28. Halima OA, Aneesh TP, Reshma G, Thomas NR. Development and validation of UV spectrophotometric method for the estimation of asenapine maleate in bulk and pharmaceutical formulation. Pharm Chem 2012;4:644-9.
29. Mrudulesh Y, Ravi Sankar P, Devadasu CH, Srinivasa Babu P. Development of a validated UV spectrophotometric method for the quantitative estimation of asenapine maleate in bulk drug. J Chem Pharm Sci 2013;6:227-30.
30. Maradiya JK, Goswami SS, Suhagia BN. A simple and reproducible estimation of some novel atypical antipsychotics by colorimetric method using bromocresol green as chromogen. Pharm Lett 2015;7:218-27.
31. Surekha ML, Swapna M, Swamy GK. New validated visible spectrophotometric methods for the estimation of triptans and asenapine maleate in bulk and in pharmaceutical dosage forms. Indo Am J Pharm Res 2013;3:4637-44.
32. Britton HTS. Hydrogen Ions. 4th Ed. Chapman and Hall; 1952.
33. Job P. Spectrochemical methods of analysis. Wiley Interscience: New York; 1971. p. 346.
34. Yoe JH, Jones AL. Determination of tungsten. Industrial and engineering chemistry. Anal Edition 1944;16:111.
35. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (2005) ICH Harmonized Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology, Q2(R 1), Complementary Guideline on Methodology, ICH, London; 1996.
36. Miller JN, Miller JC. Statistics and chemometrics for analytical chemistry. 5th ed. Prentice Hall, England; 2005.
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EL-SHEIKH, R., ELLATEIF, A. E. A., AKMAL, E., & GOUDA, A. A. (2020). DEVELOPMENT AND VALIDATION OF NEW SPECTROPHOTOMETRIC METHODS FOR ESTIMATION OF ANTIPSYCHOTIC DRUG ASENAPINE MALEATE IN PURE AND DOSAGE FORMS. International Journal of Applied Pharmaceutics, 12(4), 62-69. https://doi.org/10.22159/ijap.2020v12i4.37676
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