García BL, López AM, Martínez EV, García PCM, Fernández MA, Cárdenas PM

Language: Spanish
References: 19
Page: 1-21
PDF size: 743.54 Kb.

ABSTRACT

Introduction: The quality of the raw material destined to the pharmaceutical industry is a critical point in the development of a medicine, for which the international regulatory requirements have been increasing in order to guarantee the safety and efficacy of the drugs. In this regard, it is supervised the compliance with the good practices in the production based on reliable analysis of pharmaceutically active ingredients. For this study, ampicillin and oxacillin were selected because they are raw materials used in the manufacture of antibiotics with a broad spectrum of activity and high demand in the population.
Objective: To evaluate the performance of the analytical methods implemented in the quantification of the Active Pharmaceutical Ingredient (IFA, by its acronym in Spanish) to be used during the analysis of quality control of ampicillin and oxacillin for production.
Methods: The method of analysis used for the quantification of the Active Pharmaceutical Ingredient was the high resolution liquid chromatography of reverse phase. The evaluation was made taking into account the validation parameters attending to Category I (Class C) complying with the regulations in force in Cuba.
Results: The analytical method used for each IFA meets the established requirements of linearity in a range of 50 to 150%, CV precision  2%, selectivity and accuracy.
Conclusion: The analytical methods used in the quantification of the IFA are valid to conduct the quality control of ampicillin and oxacillin that are destined to production and permit the accomplishment of the current regulatory requirements.

REFERENCES

1. Gómez J, García-Vázquez E, Hernández-Torres A. Los betalactámicos en la práctica clínica. Revista Española de Quimioterapia. 2015;28(1):1-9.

2. Jank L, Targa Martins M, Bazzan Arsand J, Barcellos Hoff, Barreto F, Pizzolato TM. High-throughput method for the determination of residues of ß-lactam antibiotics in bovine milk by LC-MS/MS, Food Additives & Contaminants: Part A, 32-12, 1992-2001; 2015. p 1-10. DOI: 10.1080/19440049.2015.1099745

3. Amyes SGB. Antibacterial Chemotherapy: (Oxford Infectious Diseases Library) Theory, Problems, and Practice. Editorial Oxford University Press Inc. Nueva York; 2010. p.10

4. Drugs.com Know more. Be sure. [Internet] Ampicillin, Drugs information [actualizado 1 agosto 2019; acceso 20/01/2017] Disponible en: https://www.drugs.com/mtm/ampicillin.html#moreResources

5. Mensa J, Gatell JM, García Sánchez E. Guía de Terapéutica Bacteriana. Barcelona: Editorial Antares; 2016.

6. CECMED. Regulación 61. Requisitos para el registro sanitario de medicamentos de uso humano. Ámbito Regulador (Boletín). 2012;XII(158) [acceso 22/08/2019]. Disponible en: https://www.cecmed.cu/sites/default/files/adjuntos/ambitor/AmbReg- 158.pdf

7. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonized Tripartite Guideline Validation of Analytical Procedures: Text and Methodology Q2 (R1); 1994.

8. Volonté MG, Quiroga P. Análisis Farmacéutico. [Internet]. La Plata: Editorial de la Universidad Nacional de La Plata (EDULP); 2013. 350 p. [acceso 22/08/2019]. Disponible en: http://sedici.unlp.edu.ar/bitstream/handle/10915/32503/Documento_completo.pdf?sequen ce=3&isAllowed=y

9. United States Pharmacopeial Convention. USP XXXX-NF-35. Official Monographs. 22 ed. Rockville: Mack Printing; 2017. p. 2234,4647.

10. Mahdi Saeed A, Redha Hadi M, Muhsin Abid F. Bioavailability of ampicillin 500 mg capsule on healthy Iraqi volunteers by HPLC. Research Journal of Pharmaceutical, Biological and Chemical Sciences. 2017;8(4):938-44. 2017.

11. Lara FJ, Olmo-Iruela M, Cruces-Blanco C, Quesada-Molina C, García-Campaña AM. Advances in the determination of β-lactam antibiotics by liquid chromatography. TrAC Trends in Analytical Chemistry. 2012;38:52-66.

12. Mitchell JM, Grifiths MW, MC Ewen SA, MC Nab WB, Yee AJ. Antimicrobial drug residues in milk and meat: causes, concerns, prevalence, regulations, test, and test performance”. J. Food. Prot. 1998;61:742-56.

13. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline. Pharmaceutical Development Q8 (R2); 2009 [acceso 22/08/2019]. Disponible en: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R 1/Step4/Q8_R2_Guideline.pdf

14. Contreras A, Soledad-Rodríguez Beatriz E. Estandarización de un método analítico para determinar ampicilina como contaminante en bajas concentraciones, en muestras acuosas por HPLC-UV. Rev. Tekhné. 2017 [acceso 22/08/2019];20(1):001-6. Disponible en: http://revistasenlinea.saber.ucab.edu.ve/temas/index.php/tekhne/article/view/3389

15. Deshpande AD, Baheti KG, Chatterjee NR. Degradation of bb-lactam antibiotics. Current Science. 2004;87(12):1684-95.

16. Mirzaei R, Yunesian M, Nasseri S, Gholami M, Jalilzadeh E, Shoeibi S, et al. An optimized SPE-LC-MS/MS method for antibiotics residue analysis in ground, surface and treated water samples by response surface methodology- central composite design. J Environ Health Sci Eng. 2017;15:21. DOI: 10.1186/s40201-017-0282-2.

17. Frau J, Coll M, Donoso J, Munoz F, Vilanova B, Garcia-Blanco F. Alkaline and acidic hydrolysis of the β-lactam ring. Electronic Journal of Theoretical Chemistry. 1997;2:56– 65.

18. Zhang K, Zhou X, Du P, Zhang T, Cai M, Sun P, Huang C. Oxidation of β-lactam antibiotics by peracetic acid: Reaction kinetics, product and pathway evaluation. Water Research. 2017;123:153-61.

19. Mitchell MS, Ullman LJ, Teel LA, Watts JR. pH and temperature effects on the hydrolysis of three β-lactam antibiotics: Ampicillin, cefalotin and cefoxitin Science of The Total Environment. 2014;466-467(1):547-55.