A NOVEL UV SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION OF DALFAMPRIDINE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Sandeep K.*, Suresh D. N. and Naveen Kumar G. S.

ABSTRACT

Simple, precise and accurate area under curve spectroscopic method has been developed and validated for the estimation of Dalfampridine in bulk and pharmaceutical dosage form. The drug shows maximum absorption (λ max) at 262nm in 0.1M HCL solution and Area under Curve [AUC] in absorption spectra were measured between the wavelength range 257 to 267nm which obeys Beer’s law in the concentration range of 0.5-3μg/ml. The linearity study carried and regression coefficient was found to be 0.9975 and it has showed good linearity, precision during this concentration range. The % recovery was found to be 99.17%-100.53%. The LOD and LOQ were found to be 0.33 and 1.023μg/ml. The % relative standard deviation were found less than 2. According to ICH guidelines the method has been validated for linearity, precision, accuracy, robustness, ruggedness, LOD and LOQ. The developed and validated method can be successfully applied for reliable quantification of Dalfampridine in bulk form and pharmaceutical dosage form.

Keywords: Dalfampridine, Area under curve spectroscopy, validation, pharmaceutical formulations.