SEPARATION AND ASSAY OF FOUR ANTIHISTAMINE DRUGS DIPHENHYDRAMINE, CHLORPHENIRAMINE, CYPROHEPTADINE AND FEXOFENADINE IN PHARMACEUTICAL FORMS BY A SINGLE HPLC METHOD

  • Hanan Shasho Quality Control and Pharmaceutical Chemistry Department, University of Aleppo-Syrian Arab Republic
  • Amir Alhaj Sakur Analytical Chemistry Department-University of Aleppo-Syrian Arab Republic
  • Saleh Trefi Quality Control and Pharmaceutical Chemistry Department, University of Aleppo-Syrian Arab Republic

Abstract

Objective: The objective of this study was to develop and validate a single HPLC method, in order to separate and assay four antihistamine drugs diphenhydramine, chlorpheniramine, cyproheptadine and fexofenadine in pharmaceutical forms. This method was a practical additional choice in quality control laboratories.

Methods: The chromatographic conditions comprised of a classical C18-type stationary phase (150 × 4.6 mm, 5μ), with a mobile phase consisting of, 2.5g of sodium octane sulfonic acid in a mixture of 500 ml of deionized water and 500 ml of acetonitrile, and apparent pH of 2.0 was adjusted with phosphoric acid. The flow rate was 1 ml/min; the detection wavelengths were at 220 nm, 230 nm, 265 nm and 254 nm for diphenhydramine, chlorpheniramine, cyproheptadine and fexofenadine respectively. The temperature was ambient temperature.

Results: The method was validated for linearity with correlation coefficients very close to one, the accuracy with mean recovery values between 95.0-105.0%, precision with relative standard deviations of the calculated concentrations less than 5.0% and specificity in the presence of degradation products. Then it was used successfully to separate a mixture of them and to assay these drugs in pharmaceutical forms purchased from Syria.

Conclusion: The results presented in this paper showed that the developed method was simple and applicable, for the separation and determination of the four drugs in their pharmaceutical forms.

Keywords: HPLC, Diphenhydramine, Chlorpheniramine, Cyproheptadine, Fexofenadine

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References

1. JH Block, JM Beale. Wilson, Gisvold's. Textbook of organic medicinal and pharmaceutical chemistry. 11th ed. Philadelphia: Lippincott Williams and Wilkins; 2004. p. 485-520.
2. British Pharmacopeia on Line; 2015.
3. Vinutha K, Saba M, Medidi S. Development and validation of stability-indicating HPLC method for simultaneous determination of related substances of acetaminophen and diphenhydramine hydrochloride in rapid release gel capsules. Am J Pharm Tech Res 2016;6:411-26.
4. Mohammed Al B, Gunasekar M. Simultaneous estimation of diphenhydramine hydrochloride and naproxen sodium in raw and tablet formulation by the reverse phase high-performance liquid chromatographic method. Int Res J Pure Appl Chem 2016;13:1-9.
5. Nalluri BN, Mrudula B, Chitralatha K, Sultana SA, Chandra TU. Development of stability indicating RP-HPLC-PDA method for the simultaneous analysis of naproxen sodium and diphenhydramine hydrochloride in bulk and tablet dosage forms. Indian Drugs 2015;52:40-7.
6. Hatice Ç, Ebru B. HPLC method development and validation: simultaneous determination of active ingredients in a cough and cold pharmaceuticals. Int J Pharm Pharm Sci 2014;6:421-8.
7. Vishal J, Mukesh CS. Validated RP-HPLC method for determining the levels of bromhexine HCl, chlorpheniramine maleate, dextromethorphan HBr and guaiphenesin in their pharmaceutical dosage forms. J Taibah Uni Sci 2016;10:38-45.
8. Kapildev RJ. Analytical method development and validation of RP HPLC for simultaneously estimation of chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrobromide in cough syrup. Int J Adv Sci Engin Tech 2016;4:35-9.
9. Sher N, Siddiqui FA, Hasan N, Shafi N, Zubair A, Mirza AZ. Simultaneous determination of antihistamine anti-allergic drugs, cetirizine, domperidone, chlorphenamine maleate, loratadine, meclizine and buclizine in pharmaceutical formulations, human serum and pharmacokinetics application. Anal Methods 2014;6:2704-14.
10. Sehrawat R, Khatak M, Maithani M, Khatak S. Simultaneous determination of Chlorpheniramine Maleate, paracetamol and phenylephrine hydrochloride in tablet dosage form by high-performance liquid chromatography. Int J Drug Dev Res 2013;5:258-63.
11. Fanhua C, Yumei Z, Xiaona Z. Determination of content and related substances of cyproheptadine hydrochloride tablets by HPLC. China Pharm 2015;18:1827-9.
12. Alaa El-G, Moustafa MM. HPLC and chemometric methods for the simultaneous determination of cyproheptadine hydrochloride, multivitamins, and sorbic acid. J Pharm Biomed Anal 2004;35:703-13.
13. Burrows GW, Alliger CL. High-performance liquid chromatographic determination of cyproheptadine hydrochloride in tablet formulations. J Pharm Sci 1983; 72:1212-3.
14. Agha ZM, Arayne MS, Najma S. HPLC method development, validation and its application to investigate in vitro effect of pioglitazone on the availability of H1 receptor antagonists. J Associ Arab Univ Basic Appl Sci 2017;22:70-5.
15. Ruhul K, Moniruzzaman Sarker ASM, Zakir Sultan M, Sarowar Jahan M. A simple and improved HPLC-PDA method for simultaneous estimation of fexofenadine and pseudoephedrine in extended release tablets by response surface methodology. J Chem 2017:31-6. https://doi.org/10.1155/2017/9395023
16. Barabde GR, Ambadekar SR, Ahmed AN. Comparative study of estimation of fexofenadine hydrochloride by uv-visible spectrophotometry and HPLC method. J Res Pharm Sci 2016;2:1-4.
17. Rajan VR. Determination of fexofenadine hydrochloride in pharmaceutical dosage form by reverse phase high performance liquid chromatography method. Pharm Lett 2016;8:224-8.
18. Wicharn J, Puangkaew L. Development of HPTLC method for determination of brompheniramine maleate and phenylephrine hydrochloride tablets. Int J Pharm Pharm Sci 2014;6:106-9.
19. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf [Last accessed on 10 Dec 2017]
20. United Stated Pharmacopoeia USP 38/National Formulary NF 33; 2015.
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Shasho, H., A. A. Sakur, and S. Trefi. “SEPARATION AND ASSAY OF FOUR ANTIHISTAMINE DRUGS DIPHENHYDRAMINE, CHLORPHENIRAMINE, CYPROHEPTADINE AND FEXOFENADINE IN PHARMACEUTICAL FORMS BY A SINGLE HPLC METHOD”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 10, no. 4, Apr. 2018, pp. 53-60, doi:10.22159/ijpps.2018v10i4.24819.
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