Development and validation of a new reversed-phase HPLC method for the determination of ezetimibe in pharmaceutical dosage forms

Ghanshyam Panjwani; Ragvendra Shetty; Gautham Shenoy; Dinesh Dhamecha

Development and validation of a new reversed-phase HPLC method for the determination of ezetimibe in pharmaceutical dosage forms

Ghanshyam Panjwani, Ragvendra Shetty, Gautham Shenoy, Dinesh Dhamecha

Department of Pharmaceutical Chemistry, Manipal College of Pharmaceutical Sciences, Manipal

Research output: Contribution to journal › Article › peer-review

4 Citations (Scopus)

Abstract

Ezetimibe belongs to a group of selective and very effective 2-azetidione cholesterol absorption inhibitors that act on the level of cholesterol entry into enterocytes. A new, rapid, specific reversed-phase HPLC method has been developed for assaying ezetimibe in pharmaceutical dosage forms. The assay involved an isocratic elution of ezetimibe in a Betasil C₁₈ (250 mm x 4.6 mm i.d., 5μ) column using a mobile phase composition of 18 Acetonitrile: 10 mM Na₂ HPO₄ pH 7.0 (55:45 v/v). The flow rate was 1ml/min and the analyte monitored at 233nm. The assay method was found to be linear from 4-24μg/mL. All the validation parameters were within the acceptance range. The developed method was successfully applied to estimate the amount of ezetimibe in tablets.

Original language	English
Pages (from-to)	7-12
Number of pages	6
Journal	Indian Journal of Pharmaceutical Education and Research
Volume	47
Issue number	1
Publication status	Published - 01-01-2013

All Science Journal Classification (ASJC) codes

Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

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AU - Shetty, Ragvendra

AU - Shenoy, Gautham

AU - Dhamecha, Dinesh

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AB - Ezetimibe belongs to a group of selective and very effective 2-azetidione cholesterol absorption inhibitors that act on the level of cholesterol entry into enterocytes. A new, rapid, specific reversed-phase HPLC method has been developed for assaying ezetimibe in pharmaceutical dosage forms. The assay involved an isocratic elution of ezetimibe in a Betasil C18 (250 mm x 4.6 mm i.d., 5μ) column using a mobile phase composition of 18 Acetonitrile: 10 mM Na2 HPO4 pH 7.0 (55:45 v/v). The flow rate was 1ml/min and the analyte monitored at 233nm. The assay method was found to be linear from 4-24μg/mL. All the validation parameters were within the acceptance range. The developed method was successfully applied to estimate the amount of ezetimibe in tablets.

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Development and validation of a new reversed-phase HPLC method for the determination of ezetimibe in pharmaceutical dosage forms

Abstract

All Science Journal Classification (ASJC) codes

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