Chromatographic and Spectral Analysis of Two Main Extractable Compounds Present in Aqueous Extracts of Laminated Aluminum Foil Used for Protecting LDPE-Filled Drug Vials.

Laminated aluminum foils are increasingly being used to protect drug products packaged in semipermeable containers (e.g., low-density polyethylene (LDPE)) from degradation and/or evaporation.

Chiral HPLC analysis of formoterol stereoisomers and thermodynamic study of their interconversion in aqueous pharmaceutical formulations.

A chiral HPLC method was validated and successfully applied for the determination of formoterol stereoisomers and their inversion products in an aqueous matrix stored at 5-70 degrees C up to 3 weeks. Analysis was performed on a Chiral-AGP column (100 x 4-mm, 5-microm) using a variable mixture of mobile phase A (50-mM sodium phosphate buffer, pH 7.0) and B (10% v/v IPA) at a flow rate of 1.

Compatibility and aerosol characteristics of formoterol fumarate mixed with other nebulizing solutions.

Background: Patients with chronic obstructive pulmonary disease (COPD) are often given admixtures of nebulizable drugs to minimize the time of administration in treatment regimens.

Objective: To evaluate the physicochemical compatibility and aerodynamic characteristics of formoterol fumarate 20 microg/2 mL when mixed or sequentially nebulized with budesonide inhalation suspension 0.5 mg/2 mL, ipratropium bromide 0.

SPME-GC determination of potential volatile organic leachables in aqueous-based pharmaceutical formulations packaged in overwrapped LDPE vials.

A direct liquid immersion solid-phase microextraction-gas chromatographic (SPME-GC) method was developed and validated for the determination of 11 potential volatile organic compounds that may leach from preprinted foil laminate overwrap into aqueous pharmaceutical formulations filled in low-density polyethylene (LDPE) vials. The target compounds namely, ethanol, acetone, isopropyl alcohol, ethyl acetate, 2-butanone, n-heptane, isopropyl acetate, n-propyl acetate, toluene, diacetone alcohol and 1-propoxy-2-propanol, were suitably extracted from aqueous sample solutions by SPME using a 100-microm PDMS fiber, desorbed inside the GC inlet port, and analyzed using a J&W Scientific DB-1701 (86% polydimethylsiloxane/14% cyanopropylphenyl, 30 m x 0.53 mm i.

Optimization and validation of a gas chromatographic method for analysis of (RS,SR)-diastereoisomeric impurity in formoterol fumarate.

A gas chromatographic method for the determination of formoterol (RS,SR)-diastereoisomer, a process impurity, in formoterol fumarate was optimized and validated. The method involves silylation of formoterol fumarate with N-(trimethylsilyl)imidazole in N,N-dimethylformamide at room temperature in an autosampler vial to produce trimethylsilyl derivatives of the enantiomers prior to GC analysis. The optimized silylation and separation conditions, respectively, produced good yield and resolution of the analytes.