SEPARATION AND ASSAY OF FOUR ANTIHISTAMINE DRUGS DIPHENHYDRAMINE, CHLORPHENIRAMINE, CYPROHEPTADINE AND FEXOFENADINE IN PHARMACEUTICAL FORMS BY A SINGLE HPLC METHOD
Keywords:HPLC, Diphenhydramine, Chlorpheniramine, Cyproheptadine, Fexofenadine
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 Ã— 4.6 mm, 5Î¼), 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.
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.
British Pharmacopeia on Line; 2015.
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.
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.
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.
Hatice Ã‡, 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.
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.
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.
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.
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.
Fanhua C, Yumei Z, Xiaona Z. Determination of content and related substances of cyproheptadine hydrochloride tablets by HPLC. China Pharm 2015;18:1827-9.
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.
Burrows GW, Alliger CL. High-performance liquid chromatographic determination of cyproheptadine hydrochloride in tablet formulations. J Pharm Sci 1983; 72:1212-3.
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.
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
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.
Rajan VR. Determination of fexofenadine hydrochloride in pharmaceutical dosage form by reverse phase high performance liquid chromatography method. Pharm Lett 2016;8:224-8.
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.
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]
United Stated Pharmacopoeia USP 38/National Formulary NF 33; 2015.