ABSTRACT
BACKROUND: Oxitropium bromide (OB) and formoterol fumarate dihydrate (FFD) are inhaler molecules that are widely used in the treatment of chronic lung diseases. OBJECTIVE: The goal of this work was to create a reversed phase-ultra performance liquid chromatography (RP-UPLC) technique for assay and identification of OB and FFD, as well as identification and estimate of its associated compounds in pressurized metered dose inhaler product (pMDI). METHOD: Separation of oxitropium and formoterol peaks were enhanced on a C18 (50 × 2.1 mm × 1.7 µm) UPLC column with ethylene-bridged-hybrid technology, The mobile phase consists of buffer (0.07 M KH2PO4) and acetonitrile (80:20, v/v). The detector wavelength of 210 nm, flow rate of pump 0.6 mL/min, and oven temperature for column were set at 25°C. The injection volume was 10 µL. The method run time was 2 min. The mobile phase was used as the solvent. RESULTS: Retention times (RTs) were 0.5 min for OB and 1.0 min for FFD. The assay analysis was linear range for all analytes within the range for concentrations 0.03-14.8 µg/mL of OB, 0.01-0.88 µg/mL of FFD. LOD values and LOQ values 0.009 and 0.026 µg/mL for OB and 0.003 and 0.009 µg/mL for FFD, respectively. Recoveries were obtained at 96.3% for OB and 97.2% for FFD. Precisions values were (as RSD, %) ≤1.5%. CONCLUSIONS: With the UPLC method developed and validated according to the current ICH guidelines, it is possible to simultaneously detect OB and FFD of assay analysis in pMDI products accurately, precisely and selectively, independent of the matrix effect. HIGHLIGHTS: The present method is the first method in the literature based on the UPLC method for this purpose. The UPLC method is a time-saving method, it provides a faster and cheaper technique than the high performance liquid chromatography (HPLC) method.
Subject(s)
Bronchodilator Agents , Pulmonary Disease, Chronic Obstructive , Scopolamine Derivatives , Humans , Bronchodilator Agents/therapeutic use , Chromatography, High Pressure Liquid/methods , Ethanolamines/analysis , Ethanolamines/therapeutic use , Formoterol Fumarate/therapeutic use , Pulmonary Disease, Chronic Obstructive/drug therapy , Metered Dose Inhalers , Nebulizers and VaporizersABSTRACT
A tumor-like tissue mass of lateral-limbal site in the right eye of a 12-year-old Cob Pony mare was presented for surgical removal. The mass, covering the lateral limbus, bulbar conjunctiva and part of the cornea, was surgically removed, and the corneal defect repaired with a pedicle bulbar conjunctival graft. The mass was inflammatory in nature containing mononuclear cells. No recurrence or complication occurred at 6- and 12-month follow-up examination.
