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Lafutidine (LTD) is a histamine H2 receptor antagonist, with anti-ulcer and  mucosal protective activity. A sensitive and selective stability-indicating  reversed- phase high -performance thin-layer chromatography  (RP-HPTLC)/Densitometry method is suggested for the determination of LTD in  the presence of its acid, alkaline, oxidative and dry heat degradation  products. Stress testing of LTD was done according to the International  Conference on Harmonization (ICH) guidelines in order to validate the  stability-indicating power of the analytical procedures. Stress testing  demonstrated that LTD underwent acid, alkaline, oxidative and dry heat  degradation; on the other hand, it showed stability towards neutral and photo  degradation. Chromatography was performed on aluminum-backed silica gel 60  RP-18 F254 S plates with Methanol: Water: Triethylamine 8: 2: 0.5 (v/v) as  mobile phase. Densitometric scanning was performed at 276 nm. The system gave  compact bands for LTD (Rf 0.67 ± 0.02). Linear regression analysis data for  the calibration plots discovered a good linear relationship with r2 > 0.99 in  the working concentration range 500 to 3000 ng per band. The limits of  detection and quantification were 23.51 ng and 71.26 ng, respectively. The  developed method can routinely be used for analysis of LTD in bulk and  pharmaceutical formulations

Stability-indicating reversed-phase high-performance thin-layer chromatography/densitometry estimation of lafutidine in bulk and tablets