Itraconazole (ITZ) is a potent triazole antifungal protein inhibitors agent that is prescribed to patients with fungal infections. The drug is given orally in capsule form and as liquid oral form. The IUPAC nomenclature of the drug is as follows: (2R,4S)-rel-1-(butan-2-yl)-4-4-[4-(4-[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-ioxolan-4-yl]-methoxy-phenyl)-piperazin-1-yl]phenyl-4,5-dihydro-1H-1,2,4-triazol-5-one [Figure 1].[1�C3]. Figure 1 Chemical structure of ITZ ITZ is used orally in the form of capsule for treatment of dermatophyte infections, on occurrence of superficial fungal infections and in systemic fungal infections. For quality control and stability testing of ITZ in pharmaceutical formulations, limited methods have been published.
Spectrofluorimetry method has been published for assay of ITZ in raw material and in dosage forms.[4] RP-HPLC method is published for determination of ITZ in human plasma.[5�C7] Chromatographic separation in this method was performed on an octadecylsilane column using fluorescence detector.[5] However, it has the disadvantage of being time-consuming. All these studies have further emphasized the need to perform rapid and sensitive quality-control analysis of pharmaceutical formulations containing ITZ. High-performance thin-layer chromatographic (HPTLC) method for analysis of ITZ in pharmaceutical formulations has not been reported yet. Because of rapidity, selectivity, sensitivity, and overall versatility, development of precise and validated HPTLC methods for quality control of drugs received much more attention.
[8] The objective of this study was to develop and validate a rapid, simple, sensitive, and reproducible HPTLC method for quantification of ITZ in the bulk drug and in pharmaceutical formulation that can be applicable as stability-indicating. The developed stability-indicating HPTLC method has been validated according to ICH Q2 (B) guideline.[9] MATERIALS AND METHODS ITZ was provided as a gift sample by Akums Drugs and Pharma. Ltd. Drug was used without any further purification. All other reagents used for experimentation were of analytical reagent grade. Chemicals used for this experiment were Toluene, Methanol, Chloroform, NaOH, HCl, and H2O2 purchased from Finar reagents, Ahmedabad. Itaspor capsules were used as marketed formulation of ITZ.
Batimastat Instrumentation Chromatographic separation of drug was performed on Merck TLC plate precoated with silica gel 60 F254 (10*10 cm with 250 mm thickness of layer) from E. Merck, Germany. The samples were applied onto the plates as a band width of 4 mm using desaga 100 ��l sample syringe (Hamilton, Switzerland) with applicator (Desaga). Linear ascending development was carried out in a twin through glass chamber (10*10 cm). Densitometric analysis was performed with a Desaga TLC scanner operated by ProQuant software (Version 1.06). Electronic balance (Acculab) was used for weighing purpose.
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