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Scholars Academic Journal of Pharmacy | Volume-2 | Issue-04
Development and Validation of Novel Hydrotropic Solubilization Method for Spectrophotometric Determination of Halofantrine in Pure and Solid Dosage Form
Nwodo NJ, Nnadi CO and Nnadi KI
Published: April 30, 2013 | 83 56
DOI: 10.36347/sajp
Pages: 298-303
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Abstract
Simple spectrophotometric method for assay of halofantrine, a poorly aqueous soluble drug, in pure and tablet dosage forms by the principles of single hydrotropic solubilization using 4 M sodium acetate and 5 M sodium citrate was developed and validated. Solubility of halofantrine in distilled water and each of the hydrotropes were determined. The percentage label claim of halofantrine in bulk and tablet forms was estimated spectrophotometrically. The method was validated for accuracy, linearity, precision, specificity and robustness. Findings showed that solubility of halofantrine was enhanced by a factor of 11 and 18 in 4 M sodium acetate and 5 M sodium citrate respectively. Beer-Lambert’s calibration curves were linear at concentration of 2-20 μg/mL (r2=0.999 and % RSD < 2 both intra- and inter-day). Analysis of commercial tablets were found to contain 99.6 – 101.6 % of halofantrine while % recoveries in both hydrotropes range from 99.9 to 101.4, % RSD and % CV were < 2 with low standard error. Intra- and inter-day CV were <0.40, LOQ and LOD were 0.925, 0.742 and 0.627, 0.420 in both hydrotropes respectively. The developed method was simple, specific, selective, reproducible and robust for routine analysis of halofantrine in pure and tablet dosage forms