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
Views 3685 Downloads 411
Taghreed A. Mohamed, National Organization for Drug Control and Research (NODCAR),6-Abu Hazem street, Pyramids Ave. P.O.Box 29, Giza, Egypt
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.
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.
J. Mary Adele, O'Neil 2006.The Merck Index, an encyclopedia of chemicals, drugs, and biological. USA: Whitehouse Station, vol.36, pp.864
A. Morin, J.J. Ballet" A recent overview on in vitro and in vivo immunological activities of methisoprinol" J. Allegro. Immunopath. 10, pp. 109–114, 1982.
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.
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.
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.
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.
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.
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.
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.
.X. lieu, "Improvement on the sample preparation of solutions for the determination of inosine pranobex tables" J. Yalow Fenxi Zazhi 14(1):12, 1994.
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.
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.
ICH Q2A, Validation of analytical methods: definitions and terminology, In IFPMA (ed), International Conference on Harmonization, Geneva, 1994
ICH Q2 (R1), Harmonized Tripartite Guideline: Validation of Analytical Procedures: Text and Methodology, ICH, Geneva, Switzerland, 2005, http://www.ich.org.
Personal communication; Medical Union Pharmaceuticals Co., specification. (Ismailia, Egypt) under license from: Newport Pharmaceuticals Limited Dublin-Ireland, (2010). For drug substance and drug products.
Bringer; Proceeding of the Sixth International Symposium on Instrumental Planar Chromatography. Institute for Chromatography, Bad Durkheim, 291, (1991).
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.