University of Khartoum

Optimization and Validation of Spectrophotometric and Spectrofluorometric Methods for Analysis of Primaquine in Pharmaceutical Formulations

Optimization and Validation of Spectrophotometric and Spectrofluorometric Methods for Analysis of Primaquine in Pharmaceutical Formulations

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Title: Optimization and Validation of Spectrophotometric and Spectrofluorometric Methods for Analysis of Primaquine in Pharmaceutical Formulations
Author: Altigani, Ayda Makram Nour Allah
Abstract: In this study optimization, validation and application of a spectrophotometric and Spectrofluorometric methods for the determination of primaquine diphosphate in Its pharmaceutical formulation are described. Simple, precise, sensitive and rapid Spectrophotometric and spectrofluorometric methods have been developed and validated. Method (A) is based on derivatization of the amino group of primaquine with Naphthoquinone-4-sulfonate (NQS) in alkaline medium pH 10 to form yellow product exhibiting λmax at 485 nm. Beer's law obeyed at 20-60 µg/L. The Limit of Detection (LOD) and Limit of Quantification (LOQ) were found to be 3.28 µg/mL and 9.96 µg/mL respectively. Method (B) is based on the reaction of primaquine (PQ) with Fluorescamine, PQ was found to form a highly fluorescent derivative with a wavelength of maximum emission at 480 nm after excitation at 397 nm. Beer's law obeyed at concentration 0.25-1.25µg/L. The Limit of detection (LOD) and Limit of quantification (LOQ) were found to be 0.051µg/mL and 0.154 µg/mL respectively. Method (C) is based on formation of inclusion complex between PQ with β-cyclodextrin, PQ was found to form a highly fluorescent derivative with a wavelength of maximum emission at 465 nm after excitation at 353 nm. Beer's law obeyed at concentration (0.5-2.5) µg/mL. The Limit of detection (LOD) and Limit of quantification (LOQ) were found to be 0.151 µg/mL and 0.468µg/mL respectively. All the methods were validated with respect to accuracy, precision, linearity, sensitivity, limit of detection (LOD), and limit of quantification (LOQ) according to International Conference on Harmonization tripartite guideline validation of analytical procedures text and methodology Q2 (RI), (2005). The methods were successfully applied for the determination of PQ in pharmaceutical formulations.
Description: 90page
URI: http://khartoumspace.uofk.edu/123456789/23863


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