Chromatographical method for the simultaneous determination of acetaminophen, metilparaben and propilparaben in Paracetamol Oral Solution

Authors

  • Juan Manuel Cordoví-Velázquez Centro de Estudios de Química Aplicada. Universidad de Granma, Cuba
  • Rodisnel Perdomo-Rivera Centro de Estudios de Química Aplicada. Universidad de Granma, Cuba
  • Alejandro Manuel Cordoví-Espinosa Universidad de Oriente, Santiago de Cuba, Cuba
  • Leandro León-Duharte Universidad de Oriente, Santiago de Cuba, Cuba
  • Pavel Cabrera-Pérez Laboratorio Farmacéutico Medilip, Bayamo, Cuba

Keywords:

acetaminophen; parabens; chromatography; validation.

Abstract

This work has been intended for the exhaustive validation of the method for HPLC in reverse phase for the quantification of acetaminophen, methylparaben and propylparaben in formulations of Paracetamol Oral Solution 120 mg/5 mL, of the Medilip Pharmaceutical Laboratory from Bayamo. The following parameters in the process of validation were evaluated: system suitable test, selectivity, linearity, precision, accuracy, interval of work, robustness, limits of detection and quantification. The methodologies followed according to Resolution 40/2014 of the Center for the State Control of the Quality of the Medicaments and Medical Devices as well as, the Norm Cuban NC TS 368:2010, Guide for the validation of methods of chemical assay. The proposed method was selective, linear, robust, accurate and precise for the interval of 80 to 120 %. These results demonstrate that the method for the quantification of the acetaminophen and parabens in the quality control of the finished product can be utilized.

References

MINSAP. Cuadro Básico de Medicamentos y Productos Naturales. Resolución No. 536. La Habana. Dirección de Medicamentos y Tecnologías Médicas. 2018.

VILLA-JIMÉNEZ, O. M.; ORTEGA-BETANCOURT, Y. Formulario Nacional de Medicamentos de Cuba [Versión Android]. Version 19.05.30. La Habana: Encimed 2019. Fuente de información de la Biblioteca Virtual en Salud de Cuba, perteneciente al Centro Nacional de Información de Ciencias Médicas. Infomed. http://fnmedicamentos.sld.cu/index.php?P= aplicacionAndroid

BRITISH NATIONAL FORMULARY (BNF). BNF 78. Royal Pharmaceutical Society. London : s. n., 2019. págs. 310, 444. https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd =&cad=rja&uact=8&ved=2ahUKEwiX59rRyM76AhWGUjABHT8OCu0QFnoECA4QAQ&url=https%3A%2F%2Fbnf.nice.org.uk%2F&usg=AOvVaw14JHEwbufPH2PfpJuOWsyN

U.S. PHARMACOPEIA. The United States Pharmacopeia, USP 41/The National Formulary, NF 36; U.S. Pharmacopeial Convention. Inc.: Rockville, MD 20852 2017, USA, 2018; p. 1858. ISBN: 9781936424702 1936424703, ISBN: 0195-7996. Available from https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/revisions/acetaminophen-oral-suspension-rb-notice.pdf

MINSAP. Anexo No.1 de las Buenas Prácticas para Laboratorios de Control de Medicamentos. Validación de Métodos Analíticos, Resolución CECMED No. 40/2014. La Habana: 2014.

OFICINA NACIONAL DE NORMALIZACIÓN. Norma Cubana (NC) TS 368:2010 Guía para la validación de métodos de ensayos químicos para Alimentos. 1ra. Edición. La Habana: Mayo 2010.

EUROPEAN PHARMACOPOEIA (Ph-Eur). European Pharmacopoeia. 10th Edition. 2019. pág. 2963, Electronic version. ISBN: Vol. I(737-3736), Vol II (1737-3736), Vol. III (2737-3736).

BRITISH PHARMACOPOEIA COMMISSION. British Pharmacopoeia. [ed.] The Stationery Office. Vol. 6, London, UK : MHRA, 2018. [ISBN 9780113230570]

. BARWICK, Vicki et al. “Method validation in analytical sciences: discussions on current practice and future challenges”. Accreditation and Quality Assurance, 2017, vol. 22, no 5, p. 253-263. ISSN 09491775, 14320517.

MOFFAT, A. C.; OSSELTON, M. D.; WIDDOP, B.; WATTS, J. (2011). Clarke's analysis of drugs and poisons (vol. 3). London: Pharmaceutical press. ISBN: 0-853-69473-7.

LIBRO DEL WEB DE QUÍMICA DEL NIST, SRD 69. Acetaminophen, Methylparaben, Propylparaben. [En línea] National Intitute of Standart and Technology (NIST). [Citado el: 21 de julio de 2021.] https://webbook.nist.gov/cgi/cbook.cgi?ID=C103902&Mask=20.

PUBCHEM. Acetaminophen, Methylparaben, Propylparaben. [En línea] National Library of Medicin. National Center for Biotechnology Information, 06 de mayo de 2022. [Citado el: 11 de mayo de 2022.] https://pubchem.ncbi.nlm.nih.gov/compound/Acetaminophen.

V. BARWICK (ed.). Planning and Reporting Method Validation Studies–Supplement to Eurachem Guide on the Fitness for Purpose of Analytical Methods (2019). Available from www.eurachem.org. Fecha de acceso: 20 de mayo de 2022.

WORLD HEALTH ORGANIZATION et al. “Procedure for the elaboration, revision and omission of monographs and other texts for the international pharmacopoeia”. WHO Drug Information, 2019, vol. 33, no 2, p. 174-178. ISSN 1010-9609.

BERTIL, M.; ÖRNEMAR K, U. “The fitness for purpose of analytical methods: a laboratory guide to method validation and related topics”. A laboratory guide to method validation and related topics, 2nd ed. LGC, Teddington, Middlesex, UK, 2014. ISBN 978-91-87461-59-0.

STROMGREN, S. A.; SOLOMOTIS, M. D. “Guidelines for the validation of chemical methods in food, feed, cosmetics, and veterinary products”. In: FDA, U.S., editor. 3rd ed. USA Silver Spring, MD; 2019. p. 1-39. https://www.fda.gov/media/81810/download. Fecha de acceso: 20 de mayo de 2022.

THOMPSON, M. et al. “Harmonized guidelines for single-laboratory validation of methods of analysis” (IUPAC Technical Report). Pure Appl. Chem 2002;74 (5):835-855. ISSN: 1365-3075.

AGUIRRE, LETICIA et al. Validación de métodos analíticos. Barcelona: Asociación Española de Farmacéuticos de la Industria-AEFI, 2001. pág. 331. ISBN 9788489602335.

RAMSEY, M. H.; ELLISON, S. L. R.; ROSTRON, P. Eurachem/Eurolab/ CITAC/ Nordtest/ AMC guide: “Measurement uncertainty arising from sampling. A guide to methods and approaches”. Eurachem. Retrieved January 23, 2021. 2019. Available from www.eurachem.org.

EURACHEM GUIDE. The Fitness for Purpose of Analytical Methods. A Laboratory Guide to Method Validation and Related Topics, 2nd ed. 2014. Available online: https://www.eurachem.org/index.php/publications/guides/mv. (accessed on 18 August 2020).

CANTWELL, H. Blanks in Method Validation. A Supplement to Eurachem Guide “The Fitness for Purpose of Analytical Methods”. 1st ed. 2019. Available online: https://www.eurachem.org/images/stories/Guides/pdf/MV_Guide_Blanks_supplement_EN.pdf.). Accessed on 23 october 2020.

GILLINGS, NIC et al. “EANM guideline on the validation of analytical methods for radiopharmaceuticals”. EJNMMI Radiopharmacy and Chemistry, 2020, vol. 5, no 1, p. 1-29. Available online: https://ejnmmipharmchem.springeropen.com/articles/10.1186/s41181-019-0086-z/. Accessed on 23 May 2021.

LOGOYDA, LILIYA et al. “Youden’s test of the chromatographic determination of captopril in pharmaceuticals”. International Journal of Green Pharmacy, 2017, vol. 3, no 11, p. 188-91, e-ISSN: 1998-4103.

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Published

2023-01-17

How to Cite

Cordoví-Velázquez, J. M. ., Perdomo-Rivera, R. ., Cordoví-Espinosa, A. M. ., León-Duharte, L. ., & Cabrera-Pérez, P. . (2023). Chromatographical method for the simultaneous determination of acetaminophen, metilparaben and propilparaben in Paracetamol Oral Solution. Revista Cubana De Química, 35(1), 141–166. Retrieved from https://cubanaquimica.uo.edu.cu/index.php/cq/article/view/5314

Issue

Vol. 35 No. 1 (2023)

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Artículos

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Copyright (c) 2023 Juan Manuel Cordoví-Velázquez, Rodisnel Perdomo-Rivera, Alejandro Manuel Cordoví-Espinosa, Leandro León-Duharte, Pavel Cabrera-Pérez

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