These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
Pubmed for Handhelds
PUBMED FOR HANDHELDS
Search MEDLINE/PubMed
Title: Applicational possibilities of linear and non-linear (polynomial) regression and analysis of variance. III. Stability determination of pharmaceutical preparations: stability of diclofenac-sodium in Diclofen injections. Author: Arambasić MB, Jatić-Slavković D. Journal: Boll Chim Farm; 2004 May; 143(4):155-62. PubMed ID: 15255337. Abstract: This paper presents the application of the regression analysis program and the program for comparing linear regressions (modified method for one-way, analysis of variance), writtens in BASIC program language, for instance, determination of content of Diclofenac-Sodium (active ingredient in DIKLOFEN injections, ampules á 75 mg/3 ml). Stability testing of Diclofenac-Sodium was done by isothermic method of accelerated aging at 4 different temperatures (30 degrees, 40 degrees, 50 degrees and 60 degrees C) as a function of time (4 different duration of treatment: (0-155, 0-145, 0-74 and 0-44 days). The decrease in stability (decrease in the mean value of the content of Diclofenac-Sodium (in %), at different temperatures as a function of time, is possible to describe by, linear dependance. According to the value for regression equation values, the times are assessed in which the content of Diclofenac-Sodium (in %) will decrease by 10%, of the initial value. The times are follows at 30 degrees C 761.02 days, at 40 degrees C 397.26 days, at 50 degrees C 201.96 days and at 60 degrees C 58.85 days. The estimated times (in days) in which the mean value for Diclofenac-Sodium content (in %) will by 10% of the initial values, as a junction of time, are most suitably described by 3rd order parabola. Based on the parameter values which describe the 3rd order parabola, the time was estimated in which Diclofenac-Sodium content mean value (in %) will fall by 10% of the initial one at average ambient temperatures of 20 degrees C and 25 degrees C. The times are: 1409.47 days (20 degrees C) and 1042.39 days (25 degrees C). Based on the value for Fischer's coefficien (F), the comparison of trenf of Diclofenac-Sodium content (in %) shows that, under the influence of different temperatures as a function of time, among them, depending on temperature value, there is: statistically very significant difference (P << .05) at 50 degrees C and lower toward 60 degrees C, i.e. statistically probably significant difference (P > 0.01) at 40 degrees C and lower towards 50 degrees C and there is no statistically significance difference (P >> 0.05) at 30 degrees C towards 40 degrees C.[Abstract] [Full Text] [Related] [New Search]