Validation of quantitative determination methods of diphenhyramine tablets by high performance liquid chromatography

Authors

  • S. L. Zagorodniy
  • S. O. Vasyuk

DOI:

https://doi.org/10.14739/2310-1210.2015.2.42122

Keywords:

high performance liquid chromatography (HPLC), diphenhydramine, validation studies, assay

Abstract

Aim. In order to quantify diphenhydramine tablets the methods based on reverse phase high-performance liquid chromatography with UV-spectrometry detection at 254 nm (HPLC-UV) have been used.

Methods and results. The mobile phase used a mixture of a phosphate buffer: acetonitrile (80:20). The proposed method is applied to the two dosage forms of diphenhydramine – tablets to 0.1 and 0.05, produced by various Ukrainian pharmaceutical companies. The main characteristics are validated by Pharmacopoeia of Ukraine.

Conclusion. According to the experimental data, the technique can be correctly reproduced, and is suitable for use in pharmaceutical and forensic analytic laboratories.

References

Kharkevich, D. A. (1999) Pharmakologiya [Pharmacology]. Moscow: Geotar Medicina [in Russian].

Shajdukova, L. К. (2008) Klassicheskaya narkologiya (dlya studentov, internov, ordinatorov i vrachej). [Classical Drug Addiction. (for students, interns, residents, and physicians)]. Каzan`: Institut istorii im Mardzhani AA RT. [in Russian].

Kovalenko, V. N., Viktorov, A. P. (Eds) (2008) Kompendium. 2008. [Compendium. 2008]. Kiev: Morion. [in Ukrainian].

(2008) Derzhavna farmakopeia Ukrainy [State Pharmacopoeia of Ukraine]. Kharkiv: Naukovo-ekspertnanyi farmakopeinyi tsentr. [in Ukrainian].

European Directorate for the Quality of Medicines & Health Care. (2010) European Pharmacopeia.

Raj, S. V., Kapadia, S. U., & Argekar, A. P. (1998) Simultaneous determination of pseudoephedrine hydrochloride and diphenhydramine hydrochloride in cough syrup by gas chromatography (GC). Talanta, 46, 221–225. doi:10.1016/S0039-9140(97)00277-4.

Gomez, M. R., Sombra, L., Olsina, R. A. Martínezb, L. D., & Silvab, M. F. (2005) Development and validation of a capillary electrophoresis method for the determination of codeine, diphenhydramine, ephedrine and noscapine in pharmaceuticals. Il Farmaco, 60, 85–90. doi:10.1016/j.farmac.2004.11.002.

Sabry, K. (1999). Atomic emission spectrometric determination of ephedrine, cinchonine, chlorpheniramine, atropine and diphenhydramine based on formation of ion associates with ammonium reineckate. J. of Pharmaceutical and Biomedical Analysis, 22, 697–702. doi:10.1016/S0731-7085(99)00130-2.

Basavaiah, K., & Charan, V. S. (2002) Titrimetric and spectrophotometric assay of some antihistamines through the determination of the chloride of their hydrochlorides. Il Farmaco, 57, 9–17. doi:10.1016/S0014-827X(01)01151-X.

Akram, M. El-D., & Moftah, A. M. (2010) Spectrophotometric determination of diphenhydramine hydrochloride in pharmaceutical preparations and biological fluids via ion-pair formation. Arabian Journal of Chemistry, 3(4), 265–270. doi:10.1016/j.arabjc.2010.06.014.

Tipparat, P., Lapanantnoppakhun, S., Grudpan, K., et al. (2002). Determination of diphenhydramine hydrochloride in some single tertiary alkylamine pharmaceutical preparations by flow injection spectrophotometry. J. of Pharmaceutical and Biomedical Analysis, 30, 105–112.

Barbas, C., Garcı́a, A., Saavedra, L., & Castro, M. (2000) Optimization and validation of a method for the determination of caffeine, 8-chlorotheophylline and diphenhydramine by isocratic high-performance liquid chromatography: Stress test for stability evaluation. J. of Chromatography A., 870(1–2), 97–103. doi:10.1016/S0021-9673(99)01186-3.

Mohammed, S. A., Mohsin, G., & Syed, R. (2007) A new hydrophilic interaction liquid chromatographic (HILIC) procedure for the simultaneous determination of pseudoephedrine hydrochloride (PSH), diphenhydramine hydrochloride (DPH) and dextromethorphan hydrobromide (DXH) in cough-cold formulations. J. of Pharmaceutical and Biomedical Analysis, 43, 158–167.

Özlem, A. D., Bürge, A., & Abdürrezzak, B. (2011) Simultaneous determination of potassium guaiacolsulfonate, guaifenesin, diphenhydramine HCl and carbetapentane citrate in syrups by using HPLC-DAD coupled with partial least squares multivariate calibration. Talanta, 83(5), 1601–1605. doi: 10.1016/j.talanta.2010.11.054.

Orkoula, M. G., Kontoyannisa, C. G., Markopoulouc, C. K., & Koundourellisc, J. E. (2006) Quantitative analysis of liquid formulations using FT-Raman spectroscopy and HPLC: The case of diphenhydramine hydrochloride in Benadryl. J. of Pharmaceutical and Biomedical Analysis, 41(4), 1406–1411. doi:10.1016/j.jpba.2006.02.051.

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How to Cite

1.
Zagorodniy SL, Vasyuk SO. Validation of quantitative determination methods of diphenhyramine tablets by high performance liquid chromatography. Zaporozhye medical journal [Internet]. 2015Apr.27 [cited 2024Apr.25];17(2). Available from: http://zmj.zsmu.edu.ua/article/view/42122

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Section

Problems of pharmacy