DEVELOPMENT AND VALIDATION OF A FAST AND SENSITIVE UHPLC-PDA METHOD FOR THE QUANTIFICATION OF URSOLIC ACID IN POLY(L-LACTIC ACID) NANOCAPSULES

  • BRUNA CARLETTO Postgraduate Program in Pharmaceutical Sciences, State University of Ponta Grossa, Ponta Grossa, Brazil.
  • AMANDA MARTINEZ LYRA Postgraduate Program in Pharmaceutical Sciences, State University of Ponta Grossa, Ponta Grossa, Brazil.
  • ADRIANA YURIKO KOGA Postgraduate Program in Pharmaceutical Sciences, State University of Ponta Grossa, Ponta Grossa, Brazil.
  • ANDRESSA NOVATSKI Department of Medicine, Postgraduate Program in Health Sciences, State University of Ponta Grossa, Ponta Grossa, Brazil.
  • RUBIANA MARA MAINARDES Postgraduate Program in Pharmaceutical Sciences, State University of Midwestern Parana, Guarapuava, Brazil.
  • LEANDRO CAVALCANTE LIPINSKI Department of Medicine, Postgraduate Program in Health Sciences, State University of Ponta Grossa, Ponta Grossa, Brazil.
  • PAULO VITOR FARAGO Postgraduate Program in Pharmaceutical Sciences, State University of Ponta Grossa, Ponta Grossa, Brazil.

Abstract

Objective: The aim of the present study is to develop and validation of a ultra-high performance liquid chromatography (UHPLC) method to determine the ursolic acid content and its encapsulation efficiency (EE) in lipid-core nanocapsules prepared from poly (L-lactic acid).


Methods: A simple UHPLC-PDA method was developed and validated for the quantitative determination of ursolic acid in poly(L-lactic acid) nanocapsules. The chromatographic conditions used were: RP-C18 column, isocratic mobile phase containing acetonitrile:water (92:8, v/v), flow rate of 0.8 ml/min, column temperature of 50°C, and detection at 203 nm. The following parameters were evaluated: Specificity, linearity, limits of detection and quantification, precision, accuracy, and robustness.


Results: The method was specific to the ursolic acid and linear (r=0.9998) in the range of 10–100 μg/ml. The limits of detection and quantification were 1.35 and 4.10 μg/ml, respectively. The precision was demonstrated by a relative standard deviation less than 2%. Adequate accuracy (98.35%±0.82) was obtained. Changes in flow rate, mobile phase, and column temperature did not significantly alter the peak area and the retention time of the ursolic acid. The mean EE was 99.89%.


Conclusion: The method proved to be fast, sensitive, and simple for quantifying ursolic acid in nanocapsules and was successfully used for determining the EE.

Keywords: Analytical development, Drug quantification, Lipid-core nanocapsules, Pentacyclic triterpenoid, Quality assurance, Quality control

Author Biographies

BRUNA CARLETTO, Postgraduate Program in Pharmaceutical Sciences, State University of Ponta Grossa, Ponta Grossa, Brazil.

Postgraduate Program in Pharmaceutical Sciences

AMANDA MARTINEZ LYRA, Postgraduate Program in Pharmaceutical Sciences, State University of Ponta Grossa, Ponta Grossa, Brazil.

Postgraduate Program in Pharmaceutical Sciences

ADRIANA YURIKO KOGA, Postgraduate Program in Pharmaceutical Sciences, State University of Ponta Grossa, Ponta Grossa, Brazil.

Postgraduate Program in Pharmaceutical Sciences

ANDRESSA NOVATSKI, Department of Medicine, Postgraduate Program in Health Sciences, State University of Ponta Grossa, Ponta Grossa, Brazil.

Postgraduate Program in Health Sciences

RUBIANA MARA MAINARDES, Postgraduate Program in Pharmaceutical Sciences, State University of Midwestern Parana, Guarapuava, Brazil.

Postgraduate Program in Pharmaceutical Sciences

LEANDRO CAVALCANTE LIPINSKI, Department of Medicine, Postgraduate Program in Health Sciences, State University of Ponta Grossa, Ponta Grossa, Brazil.

Postgraduate Program in Health Sciences

PAULO VITOR FARAGO, Postgraduate Program in Pharmaceutical Sciences, State University of Ponta Grossa, Ponta Grossa, Brazil.

Postgraduate Program in Pharmaceutical Sciences

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CARLETTO, B., A. M. LYRA, A. Y. KOGA, A. NOVATSKI, R. M. MAINARDES, L. C. LIPINSKI, and P. V. FARAGO. “DEVELOPMENT AND VALIDATION OF A FAST AND SENSITIVE UHPLC-PDA METHOD FOR THE QUANTIFICATION OF URSOLIC ACID IN POLY(L-LACTIC ACID) NANOCAPSULES”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 13, no. 9, Aug. 2020, pp. 161-5, doi:10.22159/ajpcr.2020.v13i9.38993.
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