Varona TN, Gutiérrez GYI, Casado MCM, Izquierdo CA, Montes de Oca PR

Language: Spanish
References: 9
Page: 296-306
PDF size: 239.69 Kb.

ABSTRACT

Introduction: the search for analytical methods that may monitor the quality of drugs is an issue of great interest in the pharmaceutical field, even more if they are directed to studying chemical markers of medicinal plants, their extracts and phytomedicines.
Objective: to validate a high-resolution liquid chromatography (HPLC) method for the quantitative determination of the L-proline amino acid as a marker substance in Murraya paniculata L. Jack tincture.
Methods: in the HPLC, the separation was performed on a C-18 (UP5ODB-150/046) column, with a mixture of phosphate buffer solution, pH adjusted to 2.4 and acetonitrile (70:30 v/v) used as mobile phase, the flow rate was 0.6 mL/min, isocratic mode with UV detection set at 440 nm. The injection volume of the sample was 20 µL. The method was validated according to category I, following international requirements.
Results: the calibration curve was linear over the concentration range tested (30-375 mg/mL), good precision was observed with a variation coefficient less than 2 %. Recovery values were within the limits for chromatographic methods (98-102 %). The method was specific since there was no-interference by additional peaks in the elution zone of the compound in question (L-proline).
Conclusions: the HPLC analytical method, validated for the quantification of L-proline amino acid in M. paniculata tincture, proved to be linear, precise, accurate and specific under the study conditions.

REFERENCES

1. Regulación No. 28. Requerimientos de los estudios de estabilidad para el registro de productos farmacéuticos nuevos y conocidos. Centro para el Control Estatal de la Calidad de los Medicamentos (CECMED). Ministerio de Salud Pública. Ministerio de Salud Pública. La Habana, Cuba. 2000. p. 4-5.

2. Regulación No. 28. Requisitos para las solicitudes de inscripción, renovación y modificación en el registro de medicamentos de origen natural de uso humano. Centro para el Control Estatal de la Calidad de los Medicamentos (CECMED). Ministerio de Salud Pública. Ministerio de Salud Pública. La Habana, Cuba. 2002.

3. Ministerio de Salud Pública. Dirección Nacional de Farmacias. Formulario Nacional Fitofármacos y Apifármacos. La Habana: Editorial Ciencias Médicas; 2010. p. 75-7.

4. Doulgkeris CM, Galanakis D, Kourounakis AP, Tsiakitzis KC, Gavalas AM, Eleftheriou PT, et al. Synthesis and pharmacochemical study of novel polyfunctional molecules combining anti-inflammatory, antioxidant, and hypocholesterolemic properties. Bioorg Med Chem Lett. 2006;6(4):825-9

5. Méndez A. The Function and Uses of L-Proline. 2010. ID 4589629.

6. Quattrochi OA, de Andrizzi SA, Laba RF. Introducción a la HPLC. Aplicación y práctica. Buenos Aires: Artes Gráficas Farro SA; 1992. p. 301-28.

7. Fernández A, Rosales I. Segundo Taller Nacional de Validación. Validación de métodos analíticos. 1996. p. 5-47.

8. ICH. International Conference on Harmonisation. Validation of Analytical Procedures: Text and Methodology. Commission of the European Communities. 2005. p. 1-10.

9. The United Stated Pharmacopoeia 33 and National Formulary 28 (USP33-NF28). Washington: The United States Pharmacopeial Convention, Inc; 2010. p. 773.