Determination of ivermectin stability by high-performance thin-layer chromatography

A rapid, sensi tive and stabi l i ty-signi fying high-performance thin-layer chromatographic (HPTLC) method was developed and validated for the quantitative estimation of ivermectin (IVM) as a bulk drug and in pharmaceutical formulations. The separation was achieved on Lichrospher TLC aluminum plates pre-coated with silica gel 60F-254 (20cm×10cm×200 :m) using n-hexane: acetone: ethylacetate (6.5: 3.5: 0.1 v/v/v) as mobi le phase. The densitometric analysis was carried out at 247 nm wavelength. Compact spots of IVM were found at Rf = 26±0.02. For proposed procedure, linearity (r2 = 0.9989), limit of quantification (24.9 ng spot−1), limit of detection (8.22 ng spot−1) recovery (98.25–100.16%), and inter as well intra-day precision (≤2.21) was found to be satisfactory. We have synthesized polymeric nanoparticles encapsulated formulat ion of ivermectin (IVM-NPs) ; ut i l izing micel lar aggregates of cross-l inked random copolymer Nisopropylacrylamide (NIPAAM) with N-vinyl-2-pyrrolidone (VP) and polyethyleneglycol monoacrylate (PEG-A) for lymphat ic targeting and i t was also quanti f ied by the developed method. IVM and formulations were subjected to acid and alkali hydrolysis, oxidation and photo-degradation. The drug undergoes degradation under acidic, basic, light and oxidation conditions. This indicates that the drug is susceptible to acid- base hydrolysis, oxidation and photo-oxidation and the developed method is selective for quantifying IVM even in the presence of degradatnts. The method was applicable for routine analysis and stability testing of IVM in pharmaceutical drug delivery systems. As the method could effectively separate the said drug from its degradation products, it can be employed as a stability indicating one.

Author(s): Mohd. Ali, Sanjar Alam, S. Ahmad, A. K. Dinda and F. J. Ahmad

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