DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING HPTLC METHOD FOR SIMULTANEOUS ESTIMATION OF OXYCLOZANIDE AND LEVAMISOLE HCl
Mrinalini C. Damle* and Sanchita A. Kale
ABSTRACT
A simple, rapid validated stability indicating HPTLC method for simultaneous estimation of Oxyclozanide and Levamisole HCl was successfully developed. This method is based on HPTLC separation followed by UV detection at 220 nm. The separation was carried out on Merck TLC aluminium sheets precoated with silica gel 60F254 using Ethyl acetate: Ammonia: TEA: Methanol (6:0.5:0.2:0.5 v/v) as a mobile phase. Oxyclozanide and Levamisole HCl gave well defined and sharp peak at Rf 0.40 ± 0.02 and 0.80 ± 0.02 at 220 nm. Calibration curve was linear in range 100-500ng/band for Oxyclozanide and 200-1000ng/band for Levamisole HCl. Stress degradation study includes acid and base hydrolysis, oxidation, and thermal and photolytic stress conditions. This method can be applied to determination of stability of Oxyclozanide and Levamisole HCl. The suitability of this HPTLC method for quantitative determination of Oxyclozanide and Levamisole HCl was proved by validation in accordance with requirements of ICH guidelines Q2A (R1).
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