Abstract
VALIDATED SPECTROPHOTOMETRIC ESTIMATION OF DIDANOSINE IN BULK AND TABLET DOSAGE FORM

Prathap S. K.*, Jose Gnana Babu C. and Tamizhmani T.

ABSTRACT

A novel, simple, accurate and precise Zero order derivative spectroscopic method was developed and validated for the estimation of Didanosine in bulk and Pharmaceutical dosage forms and has an absorption maximum at 243 nm in 0.1 N H2SO4. The Linearity was found to be in the concentration range of 5-30μg/ml and the correlation coefficient was found to be 0.999 and it has showed good linearity, reproducibility, precision in this concentration range. The regression equation was found to be Y = 0.019 X + 0.002. The % recovery values were found to be within 99.89-100.45 % showed that the method was accurate. The LOD and LOQ were found to be 0.2032 and 0.6096 μg/ ml, respectively. The % RSD values were less than 2. The present methods were accomplish the validation parameters according to ICH guidelines like accuracy, precision, linearity, range, ruggedness, limit of detection and limit of quantization. The developed method was successfully applied for the quantitative estimation of Didanosine in bulk and pharmaceutical dosage forms.

Keywords: Didanosine, Zero Order Derivative Spectroscopy, 0.1N H2SO4, Linearity, Precision, Reproducibility and Accuracy.


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