Abstract
A sensitive, selective, precise, and stability-indicating high-performance thin-layer chromatography (HPTLC) method for the analysis of naftopidil both as bulk drug and its formulations were developed and validated. The method employed TLC aluminum plates precoated with silica gel 60 F254 as the stationary phase. The solvent system consisted of toluene—ethyl acetate—methanol—triethylamine (8:2:0.5:0.3, v/v). Densitometric analysis of naftopidil was carried out in the reflectance–absorbance mode at 254 nm. This system was found to give compact spots for naftopidil (Rf value of 0.52 ± 0.02, for six replicates). Naftopidil was subjected to acid and alkali hydrolysis, oxidation, dry and wet heat treatment, and photodegradation. The drug undergoes degradation under acidic and basic conditions, oxidation, and photodegradation. Also, the degraded products were well resolved from the pure drug with significantly different Rf values. The method was validated for linearity, precision, robustness, limit of detection...
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