The influence of three different solvents on estimation of lapatinib ditosylate from bulk and pharmaceutical dosage forms was studied. The solutions of lapatinib ditosylate were prepared employing pure organic solvents namely methanol, ethanol and also in pH2.0 phosphate buffer. The solutions were scanned with in the ranges of 200 nm to 400nm. Lapatinib exhibited λmax at 263 nm in case of methanol and ethanol; however the λmax was slightly shifted to 268.5nm in pH2.0 phosphate buffer. The method obeyed Beer-Lamberts law with in the range of 5-35μg/ml concentration. The analytical parameters such as linearity, A (1%, 1 cm), LOD, LOQ, inter day precision, intraday precision, molar absorption coefficient, and sandells sensitivity were calculated. The results of analysis were validated by recovery studies. The recovery was more than 98%. The method was found to be simple, accurate, precise, economical and robust. The validation parameters were treated statistically with ANOVA and there were significant differences noticed. This study clearly indicated that the solvent is having any influence in determination of lapatinib from bulk drug as well as from the formulations. The described method has the advantage of being rapid and easy. Hence it can be applied for routine quality control analysis of lapatinib ditosylate from pharmaceutical preparation.
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