Spectrophotometric determination of ranitidine hydrochloride (RNH) in pharmaceutical formulation using 9-fluorenylmethyl chloroformate (FMOC-Cl)

Authors

  • Abdalla Ahmed Elbashir University of Khartoum, Faculty of science, Department of Chemistry, Khartoum , Sudan
  • Shahd Moutasim Merghani University of Khartoum, Faculty of science, Department of Chemistry, Khartoum 11115, Sudan

DOI:

https://doi.org/10.22270/ajprd.v6i6.454

Keywords:

Spectrophotometric, Ranitidine hydrochloride (RNH), 9-Fluorenylmethyl chloromate (FMOC-Cl).

Abstract

A new, simple and sensitive spectrophotometric method is developed for the determination of ranitidine hydrochloride (RNH). The proposed method is based upon reaction of RNH with 9-fluorenylmethyl chloroformate (FMOC-Cl) in borate buffer of pH 8.0 producing an absorption maximum at 255 nm. All parameters required for the reaction conditions are investigated. Linearity is verified with a range of 2-16 μg/mL and is described by the regression equation y = 61129 x + 0.0354 with a correlation coefficient of 0.9998 (n = 7). The limit of detection (LOD) and the limit of quantification (LOQ) were calculated as per ICH guidelines and were found to be 0.2219 and 0.6724 μg/mL, respectively. The method was successfully applied for the determination of RNH in pharmaceutical formulation. Therefore, the method can be used for routine analysis of RNH in quality control laboratories.

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Author Biographies

Abdalla Ahmed Elbashir, University of Khartoum, Faculty of science, Department of Chemistry, Khartoum , Sudan

Prof. Abdalla Ahmed Elbashir, University of Khartoum, Faculty of Science, Department of Chemistry, Khartoum 11115, Sudan,

Shahd Moutasim Merghani, University of Khartoum, Faculty of science, Department of Chemistry, Khartoum 11115, Sudan

University of Khartoum, Faculty of science, Department of Chemistry, Khartoum 11115, Sudan

References

. Narayana B, Ashwini K. Novel reagent for the spectrophotometric determination of ranitidine hydrochloride. Eurasian Journal of Analytical Chemistry. 2010; 5(2): 170-176.
2. Narayana B, Veena K, Ashwani K, et al. New reagents for the spectrophotometric determination of ranitidine hydrochloride. Eclética.Química Journal. 2010; 35(3): 109-115.
3. Darwish IA, Hussein SA, Mahmoud AM, et al. Spectrophotometric determination of H2-receptor antagonists via their oxidation with cerium(IV). Spectrochimica Acta, Part A: Molecular and Biomolecular Spectroscopy. 2008; 69(1): 33-40.
4. Sokol A, Karpinska J, Talecka R, et al. Quantification of ranitidine hydrochloride in the presence of its decomposition product by spectrophotometric methods. Application for kinetic study. Acta Poloniae Pharmaceutica. 2011; 68(2): 169-177.
5. Kiszkiel I, Starczewska B, Leśniewska B, et al. Extraction of ranitidine and nizatidine with using imidazolium ionic liquids prior spectrophotometric and chromatographic detection. Journal of Pharmaceutical and Biomedical Analysis. 2015; 106: 85-91.
6. Basavaiah K, Nagegowda P. Determination of ranitidine hydrochloride in pharmaceutical preparations by titrimetry and visible spectrophotometry using bromate and acid dyes. II Farmaco. 2004; 59(2): 147-153.
7. Darwish IA, Hussein SA, Mahmoud A, et al. A sensitive spectrophotometric method for the determination of H2-receptor antagonists by mean of N-bromosuccinimide and p-aminophenol. Acta Pharmaceutica. 2008; 58(1): 87-97.
8. Sastry CSP, Rao SG, Rao JSVML, et al. Application of azine dyes for the determination of ranitidine hydrochloride in pharmaceutical formulations. Analytical Letters. 1997; 30(13): 2377-2390.
9. Ahmad AS, Abdel Kawy M, Nebsen M. Spectrophotometric and spectrofluorimetric determination of famotidine and ranitidine using 1,4-benzoquinone reagent. Analytical Letters. 2008; 32(7): 1403-1419.
10. Rosa SS, Barata PA, Martins JM, et al. Development and validation of a method for active drug identification and content determination of ranitidine in pharmaceutical products using near-infrared reflectance spectroscopy: A parametric release approach. Talanta. 2008; 75(3): 725-733.
11. Richter P, Toral MI, Muñoz-Vargas F. Polarographic behavior and determination of ranitidine in pharmaceutical formulations and urine. Analyst. 1994; 119(6): 1371-1374.
12. Norouzi P, Ganjali MR, Daneshgar P. A novel method for fast determination of ranitidine in its pharmaceutical formulations by fast continuous cyclic voltammetry. Journal of Pharmacological and Toxicological Methods. 2007; 55(3): 289-296.
13. Arayne MS, Sultana N, Zuberi MH, et al. Simultaneous determination of metformin, cimetidine, famotidine, and ranitidine in human serum and dosage formulations using HPLC with UV detection. Journal of Chromatographic Science. 2010; 48(9): 721-725.
14. Novaković J. High-performance thin-layer chromatography for the determination of ranitidine hydrochloride and famotidine in pharmaceuticals. Journal of Chromatography. A. 1999; 846(1-2): 193-198.
15. Martinez-Gomez MA, Carril-Avilés MM, Sagrado S, et al. Characterization of antihistamine-human serum protein interactions by capillary electrophoresis. Journal of Chromatography. A. 2007; 1147(2): 261-269.
16. Wring SA, Kilpatrick KE, Hutchins JT, et al. Shorter development of immunoassay for drugs: application of the novel RIMMS technique enables rapid production of monoclonal antibodies to ranitidine. Journal of Pharmaceutical and Biomedical Analysis. 1999; 19(5): 695-707.
17. Agatonovic-Kustrin S, Wu V, Rades T, et al. Ranitidine hydrochloride X-ray assay using a neural network. Journal of Pharmaceutical and Biomedical Analysis. 2000; 22(6): 985-992.
18. Kataoka H. Derivatization reactions for the determination of amines by gas chromatography and their applications in environmental analysis. Journal of Chromatography. A. 1996; 733(1-2): 19-34.
19. Wróblewski K, Petruczynik A, Radzik I, et al. Determination of selected antiepileptic drugs in mouse brain homogenates by HPLC-DAD. Acta Chromatographica. 2017; 29(2): 219-234.
20. El-Enany NM, Abdelal A, Belal F. Spectrofluorimetric determination of sertraline in dosage forms and human plasma through derivatization with 9-fluorenylmethyl chloroformate. Chemistry Central Journal. 2011; 5(1): 56.
21. Farshchi A, Ghiasi G, Bahrami G. A sensitive liquid chromatographic method for the analysis of clarithromycin with pre-column derivatization: application to a bioequivalence study. Iranian Journal of Basic Medical Sciences. 2009; 12(1): 25-32.
22. Einarsson S, Josefsson B, Lagerkvist S. Determination of amino acids with 9-fluorenylmethyl chloroformate and reversed-phase high-performance liquid chromatography. Journal of Chromatography. A. 1983; 282: 609-618.
23. Danielson ND, Gallagher PA, Bao JJ. Chemical reagents and derivatization procedures in drug analysis. Encyclopedia of Analytical Chemistry. 2000; 7042-7076.
24. Catrinck TCPG, Dias A, Aquiar MCS, et al. A simple and efficient method for derivatization of glyphosate and AMPA using 9-fluorenylmethyl chloroformate and spectrophotometric analysis. Journal of the Brazilian Chemical Society. 2014; 25(7): 1194-1199.
25. Garside DM, Monteiro PMS, Orren MJ. A critical evaluation for the determination of amino acids in the marine environment by derivatization using 9-fluorenylmethyl chloroformate (FMOC-Cl) and reversed phase HPLC separation. African Journal of Marine Science. 1988; 6(1): 47-53.
26. ICH Q2B. Guidelines on validation of analytical procedure; Methodology. Federal Register. 1996; 60, 27464.
27. ICH Q2A. Guidelines on validation of analytical procedure; Definition and terminology. Federal Register. 1995; 60, 11260.
28. Basavaiah K, Somashekar BC. Quantitation of ranitidine in pharmaceuticals by titrimetry and spectrophotometry using potassium dichromate as the oxidimetric reagent. Journal of the Iranian Chemical Society. 2007; 4(1): 78-88.
29. Al-Ghannam S, Belal F. Spectrophotometric determination of three anti-ulcer drugs through charge-transfer complexation. Journal of AOAC International. 2002; 85(5): 1003-1008.
30. Walash MI, Belal F, Ibrahim F, et al. Kinetic spectrophotometric method for the determination of ranitidine and nizatidine in pharmaceuticals. Journal of AOAC International. 2002; 85(6): 1316-1323.
31. Hassan SSM, Mahmoud WH, Othman AM. Determination of ranitidine in pharmaceutical preparations using manual and flow injection potentiometry and spectrophotometry. Analaytica Chimica Acta. 1996; 332(1): 39-48.

Published

2018-12-06

How to Cite

Elbashir, A. A., & Merghani, S. M. (2018). Spectrophotometric determination of ranitidine hydrochloride (RNH) in pharmaceutical formulation using 9-fluorenylmethyl chloroformate (FMOC-Cl). Asian Journal of Pharmaceutical Research and Development, 6(6), 7–14. https://doi.org/10.22270/ajprd.v6i6.454