Abstract
A new and rapid high-performance thin-layer chromatographic (HPTLC) method was developed and validated for quantitative determination of Bamifylline. The HPTLC separation was achieved on an aluminum-backed layer of silica gel 60F 254 using methanol : toluene (2.5 + 7.5 v/v) as mobile phase. Quantitation was achieved by densitometric analysis at 277 nm over the concentration range of 100600 ng/spot. The method was found to give compact spot for the drug ( R f = 0.51 0.01). The linear regression analysis data for the calibration plots showed good linear relationship with r 2 = 0.9995. The method was validated for precision, recovery, repeatability, and robustness as per the International Conference on Harmonization guidelines. The minimum detectable amount was found to be 7.65 ng/spot, whereas the limit of quantitation was found to be 23.19 ng/spot. Statistical analysis of the data showed that the method is precise, accurate, reproducible, sensitive and selective for the analysis of Bamifylline. The method was successfully employed for the estimation of Bamifylline as a bulk drug and in commercially available tablet formulation.
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