SENSITIVE SPECTROPHOTOMETRIC DETERMINATION OF ACETYLCHOLINESTRASE INHIBITOR DONEPEZIL HYDROCHLORIDE IN PURE FORM AND PHARMACEUTICAL FORMULATIONS USING SULPHONPHETHALIN DYES
Keywords:
Donepezil hydrochloride, Spectrophotometry, Ion-pair complex, Sulphonphthalein dyes, Pharmaceutical formulationsAbstract
Objective: Four sensitive, selective, rapid, validated and easily reproducible spectrophotometric methods have been developed for the determination of acetylcholinesterase inhibitor donepezil hydrochloride (DNP) in pure form and in pharmaceutical formulations
Methods: The proposed methods are based on ion-pair complex formation between donepezil hydrochloride with four acidic (sulphonphthalein) dyes; namely bromocresol green (BCG), bromothymol blue (BTB), bromophenol blue (BPB) and bromocresol purple (BCP) which extracted into dichloromethane followed by the measurement of the yellow colored ion-pair complexes at 420, 413, 415 and 409 nm for DNP-BCG, DNP-BTB, DNP-BPB and DNP-BCP complexes, respectively.
Results: Beer's law was obeyed in the concentration ranges of 1.0-12 and 1.0-10 μg ml-1for (BCG or BCP) and (BTB or BPB) methods, respectively with limits of detection (LOD) of 0.16, 0.24, 0.19 and 0.25 μg/ml using BCG, BCP, BTB and BPB methods, respectively. The stoichiometry of the ion-pair complex formed between the dug and dye found to be (1:1) was determined by Job's method of continuous variations. Various analytical parameters have been evaluated and the results have been validated by statistical data.
Conclusion: The proposed methods were validated in accordance with ICH guidelines and successfully applied to the determination of donepezil hydrochloride in pure and dosage forms. Statistical comparison of the results obtained by applying the proposed methods with those of the reported method revealed good agreement and proved that there was no significant difference in the accuracy and precision between the results.
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