Development and Validation of Stability Indicating by UV Spectrophotometric Method for Determination of Ketoconazole in Both Bulk and Marketed Dosage Formulation

In this study, a simple, rapid, accurate, precise and sensitive UV-visible spectrophotometric method has been developed and validated for the determination of ketoconazole in Pharmaceutical Tablet Formulation A UV spectroscopic method which is simple, accurate and rapid is developed for the determination of ketoconazole in pharmaceutical formulations as active substance in tablets, shampoos and cream. The absorption maxima of ketoconazole solutions in methanol are recorded at 208 nm. The linearity for ketoconazole in methanol with correlation coefficient values higher than 0.999 is found in the range of 0.005–0.025 mg/ml at 208 nm, R2 = 0.9996 and 0.05–0.25 mg/ml at 296 nm, R2 = 0.9996. The limit of detection (LOD) and the limit of quantification (LOQ) accounts to 0.000597 mg/ml and 0.00181 mg/ml at 208 nm and 0.00647 mg/ml and 0.01963 mg/ml at 210 nm, respectively. The intra and interday assay is within 2% relative standard deviation. The obtained results for tablets, cream and shampoos are in good agreement with their respective product, label claims. The developed method can be successfully applied for the purpose routine analysis of ketoconazole in pharmaceutical formulations.