VALIDATED SPECTROPHOTOMETRIC METHODS FOR THE ESTIMATION OF CINNARIZINE IN BINARY MIXTURE WITH PARACETAMOL IN BULK AND TABLETS
Objectives: The aim of this work was to develop and validate new, simple, accurate, and selective spectrophotometric methods (derivative and derivative ratio spectrophotometric methods) for the determination of these drugs. These methods can be used as analytical tools in routine examination in quality control laboratories.
Methods: The first method was derivative method in which the first derivative method (1D) for determination of PCM and the second derivative method (2D) for determination of CIN. The second method was the first derivative ratio spectrophotometric method (1DD) for determination of CIN and PCM.
Results: In first method, the first derivative spectrum (1D) of PCM where PCM was determined by measuring the amplitude of the valley at 235 nm while CIN showed zero crossing spectrum, and the second derivative spectrum (2D) of CIN where CIN was determined by measuring the amplitude of the peak at 287.5 nm while PCM showed a zero value. In the second method, the first derivative ratio spectrophotometry (1DD) for CIN and PCM determination, where the amplitude at 290 and 291 nm, was selected for the determination of CIN and PCM, respectively.
Conclusions: The developed methods were applied for the determination of the cited drugs in tablets containing binary drug mixture. The methods are simple and precise and can be used for routine analysis of the labeled drugs in combined dosage forms in quality control laboratories.
2. Sweetman SC. Martindale: The Complete Drug Reference. 36th ed. London, United Kingdom: Pharmaceutical Press; 2011.
3. Rang H, Dale M, Ritter J, Moore P. Pharmacology. Vol. 5. Edinburgh: Churchill Livingstone; 2003. p. 1084.
4. Cormie P, Nairn M, Welsh J. Guidelines: Control of pain in adults with cancer: Summary of SIGN guidelines. BMJ 2008;337:1106-9.
5. Abdine H, Belal F, Zoman N. Simple spectrophotometric determination of cinnarizine in its dosage forms. Il Farmaco 2002;57:267-71.
6. Salem MY, El-Bardicy MG, El-Tarras MF, El-Zanfally ES. Simultaneous determination of domperidone maleate and cinnarizine in a binary mixture using derivative ratio spectrophotometry and classical least squares calibration. J Pharm Biomed Anal 2002;30:21-33.
7. Vinodhini C, Vaidhyalingam V, Ajithadas A, Shantha A. Simultaneous estimation of cinnarizine and domperidone in solid oral dosage form using spectrophotometric method. Indian Drugs 2002;39:491-3.
8. Salem MY, El-Zanfaly ES, El-Tarras MF, El-Bardicy MG. Simultaneous determination of domperidone and cinnarizine in a binary mixture using derivative spectrophotometry, partial least squares and principle component regression calibration. Anal Bioanal Chem 2003;375:211-6.
9. Metwally FH, Elzeany B, Darwish H. New methods for determination of cinnarizine in mixture with piracetam by spectrodensitometry, spectrophotometry, and liquid chromatography. J AOAC Int 2005;88:1666-76.
10. Zayed S. Simultaneous determination of cinnarizine and nicergoline in a binary mixture using first derivative spectra, first derivative of ratio spectra and multivariate calibration techniques. J Anal Chem 2010;65:921-8.
11. Shah PB, Patel PU. Q-absorbance ratio spectrophotometric method for the simultaneous estimation of cinnarizine and dimenhydrinate in their combined dosage form. J Pharm Sci Biosci Res 2012;2:83-7.
12. Tarkase K, Tarkase M, Dokhe M, Wagh V. Development and validation of spectrophotometric method for simultaneous estimation of cinnarizine and domperidone maleate in pure and tablet dosage form. Int J Pharm Sci Res 2012;3:2700-4.
13. Abdelrahman MM. Simultaneous determination of cinnarizine and domperidone by area under curve and dual wavelength spectrophotometric methods. Spectrochim Acta A Mol Biomol Spectrosc 2013;113:291-6.
14. Kalyankar T, Wadher S, Kulkarni P, Panchakshari P. Simultaneous estimation and development of UV spectroscopic method for determination of cinnarizine and domperidone in bulk and pharmaceutical formulation. Int J PharmTech Res 2014;6:323-9.
15. Lamie T. Simultaneous determination of cinnarizine and dimenhydrinate in binary mixture using, first derivative of ratio spectra and bivariate spectrophotometric techniques. Anal Chem Indian J 2014;14:93-9.
16. Lamie NT. Comparative study of spectrophotometric methods manipulating ratio spectra: An application on pharmaceutical binary mixture of cinnarizine and dimenhydrinate. Spectrochim Acta A Mol Biomol Spectrosc 2015;141:193-201.
17. Lamie NT, Yehia AM. Development of normalized spectra manipulating spectrophotometric methods for simultaneous determination of dimenhydrinate and cinnarizine binary mixture. Spectrochim Acta A Mol Biomol Spectrosc 2015;150:142-50.
18. Tawakkol SM, El-Zeiny MB, Hemdan A. Full spectrum and selected spectrum based chemometric methods for the simultaneous determination of cinnarizine and dimenhydrinate in laboratory prepared mixtures and pharmaceutical dosage form. Spectrochim Acta A Mol Biomol Spectrosc 2017;173:892-6.
19. Al-Ghani AM, Thabit AA, Albaser N. Simultaneous spectrophotometric estimation of cinnarizine in binary mixture with piracetam in bulk and pharmaceutical dosage forms. World J Pharm Res 2020;9:2099-113.
20. Niu SY, Wang SJ, Shi C, Zhang SS. A rapid, simple and highly sensitive second derivative synchronous fluorometric method has been developed for the simultaneous analysis of binary mixture of cinnarizine (CN) and domperidone (DOM). J Fluoresc 2008;18:227-35.
21. Walash M, Belal F, El-Enany N, Abdelal A. Second-derivative synchronous fluorometric method for the simultaneous determination of cinnarizine and domperidone in pharmaceutical preparations. Application to biological fluids. J Fluoresc 2008;18:61-74.
22. Walash MI, Belal F, El-Enany N, Abdelal A. Second-derivative synchronous fluorescence spectroscopy for the simultaneous determination of cinnarizine and nicergoline in pharmaceutical preparations. J AOAC Int 2008;91:349-59.
23. El-Sayed G, Yasin S, El Badawy A. Voltammetric behavior and determination of cinnarizine in pharmaceutical formulations and serum. Anal Lett 2008;41:3021-33.
24. Hundt H, Brown L, Clark E. Determination of cinnarizine in plasma by high-performance liquid chromatography. J Chromatogr 1980;183:378-82.
25. Nitsche V, Mascher H. Rapid high-performance liquid chromatographic assay of cinnarizine in human plasma. J Chromatogr 1982;227:521-5.
26. Rosseel M, Lefebvre R. Sensitive determination of cinnarizine in human plasma by high performance liquid chromatography and fluorescence detection. Chromatographia 1993;36:356-8.
27. Argekar A, Shah S. Simultaneous determination of cinnarizine and domepiridone maleate from tablet dosage form by reverse phase ion pair high performance liquid chromatography. J Pharm Biomed Anal 1999;19:813-7.
28. Angelov T. High-performance liquid chromatographic determination of cinnarizine in workplace air. Chromatographia 2003;58:483-5.
29. Nowacka-Krukowska H, Rakowska M, Neubart K, Kobyli?ska M. High-performance liquid chromatographic assay for cinnarizine in human plasma. Acta Pol Pharm Drug Res 2007;64:407-11.
30. Heda A, Sonawane A, Naranje G, Puranik P. A rapid determination of cinnarizine in bulk and pharmaceutical dosage form by LC. J Chem 2010;7:1080-4.
31. El-Houssini OM, Zawilla NH, Mohammad MA. Development and validation of RP-LC method for the determination of cinnarizine/ piracetam and cinnarizine/heptaminol acefyllinate in presence of cinnarizine reported degradation products. Anal Chem Insights 2013;8:99-106.
32. Kumari S, Naga S. Validated RP-HPLC method for simultaneous estimation of cinnarizine and domperidone in bulk and pharmaceutical dosage form. J Pharm Sci Innov 2013;2:46-50.
33. Navaneethan G, Karunakaran K, Elango K. Stability indicating and simultaneous determination of cinnarizine and piracetam from capsule dosage form by reversed phase high performance liquid chromatography. Indian J Chem Technol 2013;20:323-6.
34. Prahalad R, Rao RN, Konam K, Edara SR, Rathna T. Method development and validation for the simultaneous estimation of domperidone maleate and cinnarizine in a pharmaceutical formulation by Rp-Hplc method. Indo Am J Pharm Res 2013;3:8111-20.
35. Kalyankar T, Kulkarni P, Panchakshari P, Narute A. Simultaneous RP-HPLC estimation of cinnarizine and domperidone in tablet. Res J Pharm Technol 2014;7:650-4.
36. Khushbu S, Pinkal P. Development and validation of analytical method for simultaneous estimation of cinnarizine and dimenhydrinate in tablet dosage form. Int J Pharm Sci Res 2014;5:4815-9.
37. Abdelwahab NS, Abdelrahman MM, Salama FM, Ahmed AB. Determination of dimenhydrinate and cinnarizine in combined dosage form in presence of cinnarizine impurity. Eur J Chem 2015;6:475-81.
38. Sunitha KS. Method development and validation for simultaneous estimation of domperidone maleate and cinnarizine by RP-HPLC. Int J Pharm Anal Res 2015;4:183-92.
39. Lamie NT, Monir HH. Simultaneous determination of cinnarizine and dimenhydrinate in binary mixture using chromatographic methods. J Chromatogr Sci 2016;54:36-42.
40. SM EA, Hasan MH. Exploring novel isocractic HPLC method for quantitative determination of cinnarizine and piracetam in their capsule preparations. J Appl Pharm 2016;8:1-5.
41. Ahmed AB, Abdelwahab NS, Abdelrahman MM, Salama FM. Simultaneous determination of dimenhydrinate, cinnarizine and cinnarizine impurity by TLC and HPLC chromatographic methods. Bull Fac Pharm Cairo Univ 2017;55:163-9.
42. Argekar A, Powar S. Simultaneous HPTLC determination of cinnarizine and domperidone maleate in formulations. J Planar Chromatogr 1999;12:272-4.
43. Bagade S, Walode S, Charde M, Tajne M, Kasture A. Simultaneous HPTLC estimation of cinnarizine and domperidone in their combined dose tablet. Asian J Chem 2005;17:1116-26.
44. El-Kafrawy DS, Belal TS. Validated HPTLC method for the simultaneous determination of cinnarizine and dimenhydrinate in their combined dosage form. J Asso Arab Univ Basic Appl Sci 2016;19:15-22.
45. Shirode AR, Ghuge AD, Kadam VJ. HPTLC method development and validation of cinnarizine in bulk and marketed formulation. Int J Pharm Sci Res 2016;7:2416-22.
46. Abdelal A, Kitagawa S, Ohtani H, El-Enany N, Belal F, Walash M. Method development and validation for the simultaneous determination of cinnarizine and co-formulated drugs in pharmaceutical preparations by capillary electrophoresis. J Pharm Biomed Anal 2008;46:491-7.
47. Ahmed R, Supriya RS, Sheetal DR. Spectrophotometric method for simultaneous estimation of paracetamol and cinnarizine in tablet dosage forms. Res J Pharm Tech 2012;5:667-71.
48. Chauhan RJ, Master SM, Pasha T, Thakor KA, Patel PU. Development and validation of RP-HPLC method for simultaneous estimation of cinnarizine and paracetamol in their pharmaceutical dosage form. Int Bull Drug Res 2014;4:41-52.
49. Mahrouse MA, El-Zaher AA, Al-Ghani AM. Validated chromatographic methods for simultaneous estimation of cinnarizine in binary mixture with domperidone and paracetamol in tablets. Curr Pharm Anal 2019;15:429-38.
50. Branch SK. Guidelines from the international conference on harmonisation (ICH). J Pharm Biomed Anal 2005;38:798-805.
51. Pharmacopeia Commission. The United States Pharmacopeia (USP 39), (NF 34) National Formulary. Washington, DC, Rockville, MD: United States Pharmacopeia Commission; 2016.
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