Simultaneous Determination of Formoterol Fumarate and Budesonide Epimers in Metered Dose Inhaler Using Ion-Pair Chromatography

Abstract

A simple, accurate and valid ion-pairing chromatographic method was developed for the simultaneous determination of formoterol fumarate (FF) and budesonide (BUD) epimers in metered dose inhaler. The separation was performed on C-18 column using mobile phase consisting of acetonitrile:0.05 M sodium acetate buffer (40:60% v/v) containing 0.03% sodium dodecyl sulfate adjusted to pH 3.1 using increasing volumes of either TEA or orthophosphoric acid isocratically eluted at 1.0 mL/min. Quantitation was achieved with UV detection at 214 nm. The retention times were 3.22, 6.41 and 6.91 min for formoterol fumarate, budesonide epimers B and A, respectively. The linearity range was 0.05-5.0 μg/mL for formoterol fumarate and 0.5-50.0 μg/mL for budesonide. The method was validated for, linearity; lower limit of quantification, lower limit of detection accuracy and precision. The proposed method is rapid (7 min), reproducible (RSD < 2.0%) and achieves satisfactory resolution between FF and BUD B (resolution factor = 12.07). The mean recoveries of the analytes in metered dose inhaler (99.97 and 99.83% for FF and BUD, respectively) were satisfactory.

Electro-oxidation of formoterol fumarate on the surface of novel poly(thiazole yellow-G) layered multi-walled carbon nanotube paste electrode

“…The deliberated LOD and LOQ values were found to be 0.0128 µM and 0.0427 µM, respectively. The high sensing proficiency of the presented electrode associate with previous FLFT sensors is deliberated in Table 1 11 , 12 , 14 , 26 , 27 , proposing that the Poly(TY-G)LMWCNTPE provides the lowest/very nearer LOD.…”

“…Until now, a few analytical approaches such as gas chromatography 9 , liquid chromatography-mass spectrometry 10 , thin-layer chromatography, high-performance liquid chromatography (HPLC) 11 , ion-pair chromatography (IPC) 12 , spectrophotometry 13 , reversed-phase high performance liquid chromatography (RP-HPLC) 14 , and capillary electrophoresis 15 have been reported in the literature for the detection of FLFT in commercial and pharmacological samples. Nonetheless, these approaches have some drawbacks such as costly instrumentation, lengthy and time-consuming experimental procedures, and need pre-treatment, solvent extraction, and complex instrumentation.…”

Validation of In-vitro Deposition of Emitted Dose Method for Simultaneous Estimation of Formoterol Fumarate and Glycopyrrolate in combined Dry Powder Inhaler Aerosol Pharmaceutical Dosage Form

“…[8][9][10][11] Very limited analytical methods have been reported in the literature to estimate formoterol fumarate and glycopyrrolate drugs in combined aerosol formulation, which includes different chromatographic techniques, mainly with gradient elution, long runtime, and more usage of solvents and hence, less cost-effective. [12][13][14] The present investigation reports precise, linear, specific, rugged, and robust isocratic method with a short runtime, less usage of solvents, and hence, very much cost-effective for usage in the pharmaceutical industry and, guide future scientific researchers.…”