Stability of chitosan derived from lobster chitin Panulirus Argus, raw material
Keywords:
Degree of deacetylation, Potentiometric method, Chitosan, Validation of Analytical methods, StabilityAbstract
Aim: To study the stability of chitosan derived from lobster, raw material for which was developed and validated a potentiometric method for determining the degree of deacetylation of biopolymer.
Materials and Methods: We evaluated the parameters of linearity, sensitivity, robustness, accuracy, precision and specificity of a potentiometric method. Were performed stability studies with three pilot scale batches of chitosan under accelerated conditions, for six months, and shelf life during two years. Organoleptic characteristics, degree of deacetylation, loss of drying and microbiological analysis, at the beginning and end of the study, were determined.
Results and Discussion: It was shown that the developed method was linear in the range of 1.25 to 3.75 mg / mL, with a detection limit of 1 mg / mL and 3 mg / mL as the limit of quantification, specific, accurate, precise and robust, so that it can be used in quality control and stability of polymer. Chitosan raw material, kept the parameters that determine its quality, in its initial stage as well as after six months under accelerated conditions (40 ± 2 °C, RH = 75 ± 5%) and twenty-four months at room temperature (30 ± 2 °C, RH = 70 ± 5%).
Conclusion: It was shown that chitosan, stored at room temperature in a dry place, in double polyethylene bags and multilayer paper bags conserved for twenty four months their physical, chemical and microbiological properties.
Downloads
References
Kurita K. Chemical modifications of chitin and chitosan. Plenum: New York; 1986.
Roberts GAF. Structure of chitin and chitosan. Macmillan Press: New York; 1992.
Agulló E, Mato R, Peniche C, Tapia C, Heras A, Pastor de Abram A. Generalidades. Programa CYTED, CIAD y Pontificia Universidad Católica del Perú, Perú; 2004.
Argüelles W, Heras A, Acosta N, Galed G, Gallardo A, Miralles B, et al. Caracterización de quitina y quitosano. Programa CYTED, CIAD y Pontificia Universidad Católica del Perú, Perú; 2004.
Hidalgo C, Suárez Y, Fernández M. Validación de una técnica potenciométrica para determinar el grado de desacetilación de la quitosana. Ars Pharm. 2008;49:245-57.
Chatelet C, Damour O, Domard A. Influence of the degree of acetylation on some biological properties of chitosan films. Biomaterials 2001;22(3):261-8.
Ravi Kumar MNV. A review of chitin and chitosan applications. React Funct Polym. 2000;46:1–27.
García T, Roca JM. Industrialización de los crustáceos para la obtención de quitosano en ungüento con efecto cicatrizante. Ind Data. 2008;11:24-32.
Kasaai MR. Various methods for determination of the degree of N-acetylation of chitin and chitosan: a review. J Agric Food Chem. 2009;57:1667-76.
Broussignac P. Chitosan: a natural polymer not well known by the industry. Chem Ind Genie Chim. 1968;99(9):1241-7.
Muzzarelli RAA. Chitin. Pergamon Press: Oxford; 1977
Xuan J, Lirong Ch, Wei Z. A new linear potentiometric titration method for the determination of deacetylation degree of chitosan. Carbohydr Polym. 2003;54:457-63.
Parada LG, Crespín GD, Miranda R, Katime I. Caracterización de quitosano por viscosimetría capilar y valoración potenciométrica. Rev Iberoam Polím. 2004;5(1):1-16.
Hernández H, Águila E, Flores O, Viveros EL, Ramos E. Obtención y caracterización de quitosano a partir de exoesqueletos de camarón. Superficies y Vacío. 2009;22(3):57-60.
Nieto OM. Quitina. Su estudio y utilización como fármaco acelerador de la cicatrización. Tesis Doctoral. Universidad de la Habana: Cuba; 1993.
Hidalgo C, Fernández M, Nieto OM, Paneque AA, Fernández G, Llópiz JC. Estudio de quitosanos cubanos derivados de la quitina de la langosta. Rev Iberoam Polím. 2009;10:1-17.
Shap J. Quality in manufacture of medicines and other healthcare products. Pharmaceutical Press: London; 2000.
Regulación No. 41. CECMED. Validación de Métodos Analíticos. MINSAP: Cuba; 2007.
ICH Q2A. Text on Validation of Analytical Procedures; 1995.
Regulación No. 23 CECMED. Requerimientos de los estudios de estabilidad para el registro de productos farmacéuticos nuevos y conocidos. MINSAP: Cuba; 2000.
De la Paz N, Fernández M, López OD, Nogueira A, García CM, Pérez D, et al. Optimización del proceso de obtención de quitosana derivada de quitina de langosta. Rev Iberoam Polím. 2012;13(3):103-16.
United State Pharmacopeia (USP 33). United States Pharmacopoeia XXXIII and National Formulary 28st; 2010.
Beltagi AM, Abdallah OM, Ghoneimc MM. Development of a voltammetric procedure for assay of the antihistamine drug hydroxyzine at a glassy carbon electrode: Quantification and pharmacokinetic studies. Talanta. 2008;74:851–9.
Rowe RC, Sheskey PJ, Quinn ME. Chitosan. Pharmaceutical Press: Italy; 2009.
Downloads
Published
How to Cite
Issue
Section
License
The articles, which are published in this journal, are subject to the following terms in relation to the rights of patrimonial or exploitation:
- The authors will keep their copyright and guarantee to the journal the right of first publication of their work, which will be distributed with a Creative Commons BY-NC-SA 4.0 license that allows third parties to reuse the work whenever its author, quote the original source and do not make commercial use of it.
b. The authors may adopt other non-exclusive licensing agreements for the distribution of the published version of the work (e.g., deposit it in an institutional telematic file or publish it in a monographic volume) provided that the original source of its publication is indicated.
c. Authors are allowed and advised to disseminate their work through the Internet (e.g. in institutional repositories or on their website) before and during the submission process, which can produce interesting exchanges and increase citations of the published work. (See The effect of open access).
