Stability Indicating HPTLC Determination of Tadalafil Hydrochloride in Bulk Drug and Pharmaceutical Formulations
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Tadalafil Hydrochloride is a selective phosphodiesterase type 5-inhibitor. A selective, sensitive and precise stability indicating high-performance thin layer chromatography (HPTLC) method was successfully developed for quantitative estimation of tadalafil Hydrochloride in bulk drug and tablet formulation in presence of its degradation products.
Tadalafil and its degradation products were separated by using pre-coated silica gel 60F-254 aluminum plates as stationary plate and with hexane: isopropyl alcohol: acetonitrile (5:4:1 v/v/v) mobile phase. Densitometry scanning of tadalafil Hydrochloride was done by using CAMAG TLC scanner III at 285nm. The RF value of tadalafil Hydrochloride was found to be 0.65 with optimized method parameters.
The developed method was validated in terms of linearity (200-600ng/spot), precision (inter-day variation, 0.70 to 2.4% and intra-day variation, 0.069 to 0.026%), accuracy (101.3±0.50) and specificity. The limit of detection (LOD) and limit of quantitation (LOQ) were 30ng and 90ng per spot respectively. Tadalafil Hydrochloride was exposed to force degradation by acid and alkali hydrolysis, oxidation, photo degradation and thermal degradation. The drug was found to be susceptible to acid and base hydrolysis and oxidation. The validated method was successfully applied for the separation of tadalafil Hydrochloride and its degradation products. All the peaks of degraded products were resolved from the tadalafil Hydrochloride with significantly different Rf values.
As the method could effectively separate the drug from its degradation products, it can be employed as a stability indicating one.
Tadalafil Hydrochloride, Stability indicating assay, Sensitive, Validation, Tablet formulation.