Development and Validation Of UV Spectroscopic Method For Estimation Of Ivabridine HCl In Tablet Dosage Form

[摘要] To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Ivabridine HCl in tablet dosage form. The drug is freely soluble in analytical grade water. 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 analytical grade water. 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 Ivabridine HCl in tablet dosage form and also validated as per ICH guidelines. The drug is soluble in analytical grade water, slightly soluble in methanol and freely soluble in ethanol. So, the analytical grade water is used as a diluent in method. The melting point of Ivabridine HCl was found to be 194-195˚C (uncorrected). It showed absorption maxima 260 nm in analytical grade water. 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, 98.33 and 101.25% for three levels respectively. The % RSD for precision was found to be 0.54%. A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Ivabridine HCl in tablet dosage form. The method could be considered for the determination of Ivabridine HCl in quality control laboratories.

[学科分类] 药学

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