Development and Validation of UV Spectroscopic Method for Estimation of Climbazole in Climbazole Shampoo

[摘要] To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Climbazole in Climbazole shampoo. The drug is freely soluble in organic solvents such as Chloroform and Methanol. The drug was identified in terms of solubility studies and on the basis of melting point done on Melting Point Apparatus of Equiptronics. It showed absorption maxima were determined in Methanol: Water (50:50). The drug obeyed the Beer’s law and showed good correlation of concentration with absorption which reflect in linearity. The UV spectroscopic method was developed for estimation of Climbazole in shampoo dosage form and also validated as per ICH guidelines. The drug is freely soluble in organic solvents such as Methanol, Chloroform. So, the Analytical Grade Methanol: Water is used as a diluent in equal proportion for method. The melting point of Climbazole was found to be 93-94˚C (uncorrected). It showed absorption maxima 256 nm in Methanol: Water (50:50). On the basis of absorption spectrum the working concentration was set on 6µg/ml (PPM). The linearity was observed between 2-10 μg/ml (PPM). The results of analysis were validated by recovery studies. The recovery was found to be 98.75, 98.00 and 99.17% for three levels respectively. The % RSD for precision was found to be 0.47%. A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Climbazole in shampoo dosage form. The method could be considered for the determination of Climbazole in quality control laboratories.

[学科分类] 药学

[关键词] Climbazole;Development;UV Spectrophotometer;Melting Point;Assay Method;Validation;Accuracy;Linearity;Ruggedness;Precision.