A Simple TLC-Densitometric Method for the Estimation of Labetalol Hydrochioride in Tablets

摘要

A simple, rapid, and validated thin-layer chromatographic (TLC)-densitometric method has been developed for estimation of labetalol hydrochioride in tablets. Chromatography was performed on aluminum-backed silica gel 60 F_254 TLC plates using ethyl acetate-methanol-ammonia (8:2:0.2, v/v/v) as mobile phase. The TLC scanner set at 309 nm was used for direct evaluation of the chro-matogram in reflectance absorbance mode. The R_F value for labetalol hydrochioride was found to be 0.69 +- 0.02. The validated calibration range was found to be 400-2400 ng per band (r~2 = 0.9910). The method was applied for the determination of labetalol hydro-chloride in Lobet-100 tablets. The average percent labeled amount was found to be 99.51 mg per tablet. The percent recovery for labetalol hydrochioride was found in the range of 98.62-100.50% with standard deviation well below 2 indicating accuracy of the method. The suitability of this TLC-densitometric method for quantitative determination of the compound was proved by validation in accordance with the requirements of ICH guidelines. Statistical analysis proved that the method was accurate, precise, and reproducible for analysis of labetalol hydrochioride in tablets.