Assessing the impact of the automation on the variability of the «Dissolution» test results as exemplified by «Betahistine hydrochloride tablets 16 mg»
Abstract
The article analyses the results of dissolution testing of Betahistine hydrochloride 16 mg tablets using both manual and automatic sampling. The analysis showed that the data obtained with manual sampling are statistically identical to those obtained with automatic sampling in terms of average values and variance (with significance level α = 0,05), which confirms that the automation of the dissolution test does not affect the variability of test results.
About the Authors
G. F. Vasilenko
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
N. S. Dubovik
I. M. Sechenov First Moscow State Medical University
Russian Federation
Russian Federation
I. E. Shohin
I. M. Sechenov First Moscow State Medical University
Russian Federation
Russian Federation
G. N. Gildeeva
I. M. Sechenov First Moscow State Medical University
Russian Federation
Russian Federation
G. V. Ramenskaya
I. M. Sechenov First Moscow State Medical University
Russian Federation
Russian Federation
L. A. Pavlova
I. M. Sechenov First Moscow State Medical University
Russian Federation
Russian Federation
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Review
For citations:
Vasilenko G.F., Dubovik N.S., Shohin I.E., Gildeeva G.N., Ramenskaya G.V., Pavlova L.A. Assessing the impact of the automation on the variability of the «Dissolution» test results as exemplified by «Betahistine hydrochloride tablets 16 mg». The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2016;(3):53-57. (In Russ.)
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