Resumen

GARCIA PENA, Caridad M et al. Validation of the analytical method for the quality control and the stability study of neolimpilem. Rev Cubana Farm [online]. 2004, vol.38, n.2, pp.1-1. ISSN 0034-7515.

The analytical method developed for the quality control and for the stability study in the quantification of hydroxypropylmethylcellulose and sodium laurisulfate was validated by spectrophotometry with ultraviolet detection at 635 and 650 nm, respectively. Besides, the analytical results of the stability study conducted in the solution for cleaning and conservating rigid contact lens (neolimpilen) are presented. Three batches packed in two different flasks were used to carry out the study by accelerated stability and shelf life in order to prove the phsyical and chemical stability of the solution at room temperature for 24 months. In the validation of hydroxypropylmethylcellulose, teh calibration curve in the range from 0.06 to 0.l8 mg/mL showed a lineal behavior with a correlation coefficient equal to 0.99581. The statistical test for the interval and the slope was not significant. A recovery of 99.8 % was obtained in the studied concentration range and Cochran (G) and Student's (t) tests were not indicative. The variation coefficient in the repeatabililty was 0.9 % for 10 tested replicas,. whereas Fischer and Student's tests were not significant in the reproducibility. The method proved to be specific, lineal, precise and exact. In the validation of sodium laurisulfate the calibration curve in the range 1.44 -3.0 mg/mL behaved in a lineal way with a correlation coefficient equal to 0.99036. The statistical test for the interval and the slope was not signficant. A recovery of 99.9% was attained in the studied concentration range and Cochran (G) and Student's (t) tests were not significant. The method proved to be specific, lineal, precise and exact.

Palabras clave : Hydroxypropylmethylcellulose; sodium laurisulphate; spectrophotometry; neolimpilen.