Validated Analytical Method Development of Inosine Pranobex in Drug Products by Thin Layer Chromatography

Taghreed A. Mohamed

doi:doi:10.11648/j.sjac.20140206.11

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Validated Analytical Method Development of Inosine Pranobex in Drug Products by Thin Layer Chromatography

Taghreed A. Mohamed

Published in Science Journal of Analytical Chemistry (Volume 2, Issue 6)

Received: 8 October 2014 Accepted: 28 October 2014 Published: 10 November 2014

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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.

Published in	Science Journal of Analytical Chemistry (Volume 2, Issue 6)
DOI	10.11648/j.sjac.20140206.11
Page(s)	59-66
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2014. Published by Science Publishing Group

Keywords

Inosine Pranobex, Inosine, Acetamidobenzoic Acid, TLC-Densitometry Method, Dimethylaminoisopropanol

References

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[3]	G.G. Gascony "Randomized treatment study of inosiplex versus combined inosiplex and intraventricular interferon- alpha in sub-acute sclerosing pan encephalitis (SSPE): international multicenter study" J. Child Neurol., 18 (12), pp. 819–827, 2003.
[4]	S.K. Toy "Efficacy of inosine pranobex oral therapy in subclinical human papillomavirus infection of the vulva: a randomized double-blinded placebo controlled study" Int. J. STD AIDS, 7, pp. 276–280, 1996.
[5]	S. Georgia, A. Katoulis, A. Befog, et al. "Oral inosiplex in the treatment of cervical condylomata acuminate: a randomized placebo-controlled trial" J. BJOG, 113, pp. 1088–1091, 2006.
[6]	C.De Simone, G. Facular, S. Tzantzoglou, et al. "Inosine pranobex in the treatment of HIV infection: a review" Int. J. Immunopharmacol., 13 (Suppl. 1) pp. S19–S27, 1991.
[7]	M. Rzewski, R. Macho, J.A. Hunter, et al. "Randomized, double blind, placebo controlled trial of inosine pranobex in rheumatoid arthritis" J. Ann. Rheum. , 49, pp. 293–295, 1990.
[8]	S. Georgia, A.C. Katoulis, A. Befog, et al. "Inosiplex for treatment of alopecia aerate: a randomized placebo-controlled study" J.Derm. Venereal, 86, pp. 422–424, 2006.
[9]	D. Streeter , E. H. Pfadenhauer," Inosiplex: metabolism and excretion of the dimethylaminoisopropanol and p-acetamidobenzoic acid components in rhesus monkeys" J. DMD, vol. 12 no. 2 199-203, 1984.
[10]	.X. lieu, "Improvement on the sample preparation of solutions for the determination of inosine pranobex tables" J. Yalow Fenxi Zazhi 14(1):12, 1994.
[11]	E. Dreassi, L. Celeste, G. Ceramelli, L. Savini, & P. Corte," Thin-layer chromatography in pharmaceutical quality control. Assay of inosiplex in different pharmaceutical forms". J. Pharmaceutical Acta Helvetia. 67 (12): 341-345, 1992.
[12]	Mo. Chena, Yuan. Zhanga, Xiao-Ting. Quea, Ya. Dinga, Lin. Yangb, Ai-Dong. Wen, Tai-Jun. Hang." Pharmacokinetic study of inosiplex tablets in healthy Chinese volunteers by hyphenated HPLC and tandem MS techniques" J. Pharmaceutical analysis 3(6), 387-393, 2013.
[13]	ICH Q2A, Validation of analytical methods: definitions and terminology, In IFPMA (ed), International Conference on Harmonization, Geneva, 1994
[14]	ICH Q2 (R1), Harmonized Tripartite Guideline: Validation of Analytical Procedures: Text and Methodology, ICH, Geneva, Switzerland, 2005, http://www.ich.org.
[15]	Personal communication; Medical Union Pharmaceuticals Co., specification. (Ismailia, Egypt) under license from: Newport Pharmaceuticals Limited Dublin-Ireland, (2010). For drug substance and drug products.
[16]	Bringer; Proceeding of the Sixth International Symposium on Instrumental Planar Chromatography. Institute for Chromatography, Bad Durkheim, 291, (1991).
[17]	Aboul Enein, H.Y., El-Awady, M.I., & Heard, C.M." Validated stability indicating methods for determination of nitazoxanide in presence of its degradation products". J. Pharm.Biomed.Anal. 32(1), 55, 2003.

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Taghreed A. Mohamed. (2014). Validated Analytical Method Development of Inosine Pranobex in Drug Products by Thin Layer Chromatography. Science Journal of Analytical Chemistry, 2(6), 59-66. https://doi.org/10.11648/j.sjac.20140206.11

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ACS Style

Taghreed A. Mohamed. Validated Analytical Method Development of Inosine Pranobex in Drug Products by Thin Layer Chromatography. Sci. J. Anal. Chem. 2014, 2(6), 59-66. doi: 10.11648/j.sjac.20140206.11

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Taghreed A. Mohamed. Validated Analytical Method Development of Inosine Pranobex in Drug Products by Thin Layer Chromatography. Sci J Anal Chem. 2014;2(6):59-66. doi: 10.11648/j.sjac.20140206.11

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@article{10.11648/j.sjac.20140206.11,
  author = {Taghreed A. Mohamed},
  title = {Validated Analytical Method Development of Inosine Pranobex in Drug Products by Thin Layer Chromatography},
  journal = {Science Journal of Analytical Chemistry},
  volume = {2},
  number = {6},
  pages = {59-66},
  doi = {10.11648/j.sjac.20140206.11},
  url = {https://doi.org/10.11648/j.sjac.20140206.11},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.sjac.20140206.11},
  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.},
 year = {2014}
}

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TY  - JOUR
T1  - Validated Analytical Method Development of Inosine Pranobex in Drug Products by Thin Layer Chromatography
AU  - Taghreed A. Mohamed
Y1  - 2014/11/10
PY  - 2014
N1  - https://doi.org/10.11648/j.sjac.20140206.11
DO  - 10.11648/j.sjac.20140206.11
T2  - Science Journal of Analytical Chemistry
JF  - Science Journal of Analytical Chemistry
JO  - Science Journal of Analytical Chemistry
SP  - 59
EP  - 66
PB  - Science Publishing Group
SN  - 2376-8053
UR  - https://doi.org/10.11648/j.sjac.20140206.11
AB  - 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.
VL  - 2
IS  - 6
ER  -

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Author Information

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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Taghreed A. Mohamed. (2014). Validated Analytical Method Development of Inosine Pranobex in Drug Products by Thin Layer Chromatography. Science Journal of Analytical Chemistry, 2(6), 59-66. https://doi.org/10.11648/j.sjac.20140206.11

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ACS Style

Taghreed A. Mohamed. Validated Analytical Method Development of Inosine Pranobex in Drug Products by Thin Layer Chromatography. Sci. J. Anal. Chem. 2014, 2(6), 59-66. doi: 10.11648/j.sjac.20140206.11

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AMA Style

Taghreed A. Mohamed. Validated Analytical Method Development of Inosine Pranobex in Drug Products by Thin Layer Chromatography. Sci J Anal Chem. 2014;2(6):59-66. doi: 10.11648/j.sjac.20140206.11

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@article{10.11648/j.sjac.20140206.11,
  author = {Taghreed A. Mohamed},
  title = {Validated Analytical Method Development of Inosine Pranobex in Drug Products by Thin Layer Chromatography},
  journal = {Science Journal of Analytical Chemistry},
  volume = {2},
  number = {6},
  pages = {59-66},
  doi = {10.11648/j.sjac.20140206.11},
  url = {https://doi.org/10.11648/j.sjac.20140206.11},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.sjac.20140206.11},
  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.},
 year = {2014}
}

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TY  - JOUR
T1  - Validated Analytical Method Development of Inosine Pranobex in Drug Products by Thin Layer Chromatography
AU  - Taghreed A. Mohamed
Y1  - 2014/11/10
PY  - 2014
N1  - https://doi.org/10.11648/j.sjac.20140206.11
DO  - 10.11648/j.sjac.20140206.11
T2  - Science Journal of Analytical Chemistry
JF  - Science Journal of Analytical Chemistry
JO  - Science Journal of Analytical Chemistry
SP  - 59
EP  - 66
PB  - Science Publishing Group
SN  - 2376-8053
UR  - https://doi.org/10.11648/j.sjac.20140206.11
AB  - 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.
VL  - 2
IS  - 6
ER  -

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