Validated Analytical Method Development of Inosine Pranobex in Drug Products by Thin Layer Chromatography
Science Journal of Analytical Chemistry
Volume 2, Issue 6, November 2014, Pages: 59-66
Received: Oct. 8, 2014; Accepted: Oct. 28, 2014; Published: Nov. 10, 2014
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Author
Taghreed A. Mohamed, National Organization for Drug Control and Research (NODCAR),6-Abu Hazem street, Pyramids Ave. P.O.Box 29, Giza, Egypt
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Abstract
Thin layer chromatography (TLC) with densitometry has been established for the identification and the quantification of inosine pranobex in drug substance and drug products. Inosine pranobex is a combination of inosine, acetamidobenzoic acid, and dimethylaminoisopropanol. UV densitometry was performed in absorbance mode at 260 nm. The separation was carried out on aluminum sheet of silica gel 60 f 254 [chloroform - methanol- - toluene -10% ammonia solution (6:5:1: 0.1% v/v)] as mobile phase. Linearity range was found to be 1-12, 2-12, 2-20 and 2-16 µg/ml for inosine pranobex, inosine, acetamidobenzoic acid, and dimethylaminoisopropanol with the mean percentage recoveries 99.74± 1.73%, 99.88 ± 1.75%, 99.56 ±1.08%, and 99.36 ± 0.71% respectively, (Correlation coefficient r2 = 0.9998 for inosine pranobex, r2 = 0.09999 for inosine, r2 = 0.9998 for acetamidobenzoic acid and r2= 0.9998 for dimethylaminoisopropanol). The detection and quantification limits for inosine pranobex and other components are also reported. The presented method was validated according to ICH guidelines. Statistical comparison of the results was performed using Student's t-test and F-ratio at 95% confidence level, and there was no significant difference between the reference and proposed method with regard to accuracy and precision. It could be said that the validated TLC-densitometry method is suitable for the routine analysis of inosine pranobex in quantity control laboratories.
Keywords
Inosine Pranobex, Inosine, Acetamidobenzoic Acid, TLC-Densitometry Method, Dimethylaminoisopropanol
To cite this article
Taghreed A. Mohamed, Validated Analytical Method Development of Inosine Pranobex in Drug Products by Thin Layer Chromatography, Science Journal of Analytical Chemistry. Vol. 2, No. 6, 2014, pp. 59-66. doi: 10.11648/j.sjac.20140206.11
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