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Determination of Nebivolol Hydrochloride and Hydrochlorothiazide in Tablets by First-Order Derivative Spectrophotometry and Liquid Chromatography

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Two simple and accurate methods for analysis of nebivolol hydrochloride (NEB) and hydrochlorothiazide (HCTZ) in their combined dosage forms were developed using first-order derivative spectrophotometry and reversed-phase liquid chromatography (LC). NEB and HCTZ in their combined dosage forms (tablets) were quantified using first-derivative responses at 294.6 and 334.6 nm in the spectra of their solutions in methanol. The calibration curves were linear in the concentration range of 840 g/mL for NEB and 1060 g/mL for HCTZ. LC analysis was performed on a Phenomenex Gemini C18 column (250 4.6 mm id, 5 m particle size) in the isocratic mode with 0.05 M potassium dihydrogen phosphateacetonitrilemethanol (30 + 20 + 50, v/v/v; pH 4) mobile phase at a flow rate of 1 mL/min. Detection was made at 220 nm. Both of the drugs and the internal standard (ezetimibe) were well resolved with retention times of 5.1 min for NEB, 2.9 min for HCTZ, and 8.2 min for ezetimibe. The calibration curves were linear in the concentration range of 114 g/mL for NEB and 0.328 g/mL for HCTZ. Both methods were validated and found to be accurate, precise, and specific, and results were compared statistically. Developed methods were successfully applied for the estimation of NEB and HCTZ in their combined dosage forms.
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Document Type: Research Article

Affiliations: 1: Anand Pharmacy College, Opposite Town Hall, Shri. Ramkrishna Seva Mandal Campus, Anand388 001, Gujarat, India. 2: A.R. College of Pharmacy, Vallabh Vidyanagar-388 120, Gujarat, India.

Publication date: 2008-09-01

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  • The Journal of AOAC INTERNATIONAL publishes refereed papers and reviews in the fields of chemical, biological and toxicological analytical chemistry for the purpose of showcasing the most precise, accurate and sensitive methods for analysis of foods, food additives, supplements and contaminants, cosmetics, drugs, toxins, hazardous substances, pesticides, feeds, fertilizers and the environment available at that point in time. The scope of the Journal includes unpublished original research describing new analytical methods, techniques and applications; improved approaches to sampling, both in the field and the laboratory; better methods of preparing samples for analysis; collaborative studies substantiating the performance of a given method; statistical techniques for evaluating data. The Journal will also publish other articles of general interest to its audience, e.g., technical communications; cautionary notes; comments on techniques, apparatus, and reagents.
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