title: A Rapid Stability-Indicating RP-HPLC Method for the Determination of Betaxolol Hydrochloride in Pharmaceutical Tablets.
abstract: A stability-indicating reversed-phase high performance liquid chromatography (RP-HPLC) method was developed for the determination of betaxolol hydrochloride, a drug used in the treatment of hypertension and glaucoma. The desired chromatographic separation was achieved on a Nucleosil C18, 4 μm (150 × 4.6 mm) column, using isocratic elution at a 220 nm detector wavelength. The optimized mobile phase consisted of a 0.02 M potassium dihydrogen phosphate: methanol (40:60, v/v, pH 3.0 adjusted with o- phosphoric acid) as solvent. The flow rate was 1.6 mL/min and the retention time of betaxolol hydrochloride was 1.72 min. The linearity for betaxolol hydrochloride was in the range of 25 to 200 μg/mL. Recovery for betaxolol hydrochloride was calculated as 100.01%-101.35%. The stability-indicating capability was established by forced degradation experiments and the separation of unknown degradation products. The developed RP-HPLC method was validated according to the International Conference on Harmonization (ICH) guidelines. This validated method was applied for the estimation of betaxolol hydrochloride in commercially available tablets.
authors.affiliation: Unit of Pharmacy, Hôpital Jean Verdier (APHP), Bondy, France.
authors.forename: Sylvain
authors.initials: S
authors.lastname: Auvity
authors.forename: Fouad
authors.initials: F
authors.lastname: Chiadmi
authors.forename: Salvatore
authors.initials: S
authors.lastname: Cisternino
authors.forename: Jean-Eudes
authors.initials: JE
authors.lastname: Fontan
authors.forename: Joël
authors.initials: J
authors.lastname: Schlatter
keywords: betaxolol hydrochloride; chromatography; forced degradation; method validation; tablet drug product