DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR ESTIMATION OF ALCAFTADINE IN BULK AND ITS FORMULATION

A simple, precise, accurate and rapid high performance thin layer chromatographic method has been developed and validated for estimation of Alcaftadine in bulk and Eye Drops. The chromatographic development was carried out on aluminium plates precoated with silica gel 60 F₂₅₄, as a stationary phase. A mixture of Chloroform: Methanol: Triethylamine (4:1:0.5 v/v/v) was used as mobile phase which offered a compact and dense spot of Alcaftadine. Detection was carried out densitometrically at 282 nm. The R_f value of drug was found to be 0.45± 0.02. The method was validated with respect to linearity, accuracy, precision, robustness and ruggedness. The calibration curve was found to be linear over a range of 250-1500 ng/µl. Recovery studies were performed at three concentration levels to defend suitability, accuracy and precision of developed method. The LOD and LOQ for Alcaftadine were 9.27ng and 28.1ng respectively. The proposed HPTLC method was found to provide a faster and cost-effective quantitative control for routine analysis of Alcaftadine as bulk drug and in its pharmaceutical formulation.

Key words: Alcaftadine, HPTLC, Validation, Eye drops, LOD, LOQ.