No abstract

A simple, precise bioanalytical UPLC Tandem Mass Spectroscopy gradient elution method was developed and validated for simultaneous estimation of Olmesartan Medoximil (OLM) and Metoprolol Succinate (MET) in human plasma. The quantitation carried out using Shimadzu Shimpack-C18 GIST AQ (50 mm X 2.1 mm, 1.9 µm) column and the mobile phase A comprises of 0.1% formic acid and mobile phase B as acetonitrile used for gradient elution. Analysis completed within run time of 4 min at the mobile phase flow rate of 0.3mL/min. The retention time of metoprolol succinate and olmesartan medoximil were 1.029 min and 2.514min, respectively. Analytes were extracted using acetonitrile as extracting solvent. The method validated in terms of linearity, accuracy, precision, lower limit of quantitation, method sensitivity and various solution stability parameters. Linearity of olmesartan medoximil and metoprolol succinate was in the range of 5-1500ng/mL. All the method validation parameters were determined as per ICH, EMA and FDA guidelines and falls under the stated acceptance criteria. The presented work provides a validated bioanalytical method for simultaneous determination of olmesartan medoximil and metoprolol succinate in human plasma. The method is accurate, simple, precise, fast and suitable for its application for bioequivalence and pharmacokinetic studies.

Aim and Backrgound:A simple, rapid, precise and isocratic RP-HPLC (Reverse Phase High Performance Liquid Chromatography) method is aimed to develop for the simultaneous estimation of Olmesartan Medoxomil and Metoprolol Succinate in bulk drug and pharmaceutical dosage form.Materials and Methods:The quantification is carried out using YMC-Pack CN (250 × 4.6 mm, 5.0 μm) column and the mobile phase comprises of 0.05% Trifluoro acetic acid (TFA) and Acetonitrile (ACN) (70:30 v/v). The flow rate is 1.0 ml/min. The eluent is monitored at 220 nm. The retention times of Olmesartan Medoxomil and Metoprolol Succinate are 7.9 min and 4.1 min respectively. The method is validated in terms of linearity, precision, accuracy, specificity, limit of detection and limit of quantitation.Results:Linearity and percentage recoveries of both Olmesartan Medoxomil and Metoprolol Succinate are in the range of 5-35 μg/ml and 100 ± 2%, respectively. The stress testing of both the drugs individually and their mixture is carried out under acidic, alkaline, oxidation, photo-stability and thermal degradation (dry heat and wet heat) conditions and its degradation products are well resolved from the analyte peaks.Conclusion:This method was successfully validated for accuracy, precision, and linearity.