VALIDATED ANALYTICAL METHODS FOR THE ESTIMATION OF LUMEFANTRINE IN TABLETS

A HPTLC, UV spectrophotometric and ion pair extraction method were developed and validated for the estimation of lumefantrine in tablets. The parameters linearity, precision, specificity, robustness, limit of detection and limit of quantitation were studied according to “The International Conference on Harmonization Guidelines” for validation of analytical procedures. The HPTLC method was performed using precoated silica gel plates GF60254 with mobile phase ratio consisting of methanol : chloroform : ammonia (8:2:0.05 v/v/v). Densitometric scanning was performed at 268 nm. The Rf value was found to be 0.66. The linearity range were in the concentration range of 100- 500 ng/spot, 2-16 μg/ml, 5-25 μg/ml for HPTLC (method 1), UV spectrophotometric (method 2) and ion pair extraction method (method 3). The intraday precision and Interday precision were found to be less than 2 for all the three methods. The limit of detection and limit of quantitation were found to be 25 ng/spot and 50 ng/spot for method 1, 0.5 μg/ml and 1 μg/ml for method 2 and 2μg/ml and 4 μg/ml for method 3. Statistical analysis by student’s t-test showed no significant difference between the results obtained by methods (p = 0.19497). The proposed methods are highly sensitive, precise and accurate and can be used for the routine quantitation of lumefantrine in tablets.