Development and validation of a stability indicating RP-TLC/densitometric method for determination of Loratadine in bulk and in tablets

AbstractA new rapid, economical and environmentally friendly Reversed-Phase Thin-Layer chromatography (RP-TLC)/densitometry has been developed and validated for quantitative determination of Loratadine (LOR) in bulk and in tablets. RP-TLC separation was achieved on aluminium plates precoated with silica gel 60RP-18F 254S as the stationary phase using methanol:acetonitrile (90:10%v/v) as mobile phase. Quantitation was performed at 247nm over the concentration range of 200–1200ng/band. The method was found to give compact and well resolved band for LOR at retention factor (Rf) 0.58±0.02. The linear regression analysis data for calibration graph showed good linear relationship with r2=0.998. The method was validated for recovery, precision, robustness, ruggedness and sensitivity as per International conference on Harmonisation (ICH) guidelines. The minimum detectable amount and limit of quantitation were found to be 19.40ng and 61.51ng, respectively. LOR was subjected to hydrolysis in acid, alkali, oxidation, photo-degradation and neutral condition. The drug demonstrated degradation under acid and alkali conditions. Statistical analysis proves that the method is sensitive, selective, precise and accurate for the estimation of LOR. The proposed developed RP-TLC/densitometry method can be applied for identification and quantitative determination of LOR in bulk drug and pharmaceutical dosage forms