Abstract
DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR ESTIMATION OF CIDOFOVIR DIHYDRATE IN CIDOFOVIR INJECTION

Kalyani S. Shewale*, Shruti D. Pawar, Manudip S. Deore, Sanket A. Bagad, Rakesh S. Ahire and Nishant B. Chinchore

ABSTRACT

Objective: To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Cidofovir Dihydrate in Cidofovir Injection form. Methods: The drug is soluble in 0.1 N Sodium Hydroxide. 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 0.1 N Sodium Hydroxide. 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 Cidofovir in injection form and also validated as per ICH guidelines. Results: The drug is freely soluble in 0.1 N Sodium Hydroxide, sparingly soluble in Methanol, Ethanol and insoluble in Chloroform. So, the 0.1 N Sodium Hydroxide is used as a diluent in method. The melting point of Cidofovir was found to be 258-259˚C (uncorrected). It showed absorption maxima 290 nm in 0.1 N Sodium Hydroxide. On the basis of absorption spectrum the working concentration was set on 30 μg/ml (PPM). The linearity was observed between 10-50 μg/ml (PPM). The results of analysis were validated by recovery studies. The recovery was found to be 100, 99 and 98.6% for three levels respectively. The % RSD for precision and ruggedness was found to be 0.82% and 0.19% respectively. Conclusion: A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Cidofovir in tablet dosage form. The method could be considered for the determination of Cidofovir in quality control laboratories.

Keywords: Cidofovir, UV Spectrophotometer, Melting Point, Assay Method, Validation, Accuracy, Linearity, Ruggedness, Precision.


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