A validated spectrophotometric method for determination of formoterol fumarate dihydrate in bulk and dosage form using methyl orange as ion pair reagent

Taşkın, Duygu; Erensoy, Gizem; Sungur, Sıdıka

doi:10.12991/mpj.20162030844

Marmara Pharm J

2016

DOI: 10.12991/mpj.20162030844

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A validated spectrophotometric method for determination of formoterol fumarate dihydrate in bulk and dosage form using methyl orange as ion pair reagent

Duygu Taşkın

Gizem Erensoy

Sıdıka Sungur

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Cited by 8 publications

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References 19 publications

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“…It is used to treat asthma and allergic rhinitis. Extensive literature survey revealed that there were ultraviolet spectroscopic methods for the estimation of Formoterol fumarate alone 1,2 and with other combinations. 3,4 An ultraviolet spectroscopic method has been developed for Fluticasone propionate 5 and in combination with Salmeterol xinafoate.…”

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Development and Validation of Ultra Performance Liquid Chromatographic Method for the Analysis of Pulmonary Drug Product Containing Formoterol Fumarate and Fluticasone Propionate

Chengalva¹,

Kuchana²

2018

Int. Res. J. Pharm.

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An ultra-performance liquid chromatographic assay method was developed for the simultaneous determination of Formoterol fumarate and Fluticasone propionate in dry powder inhalation formulation. The separation was achieved on Acquity UPLC HSS C18 (50 mm x 4.6 mm x 1.8 µm) column. The mobile phase consists of water (p H adjusted to 2.5 with orthophosphoric acid): acetonitrile (40:60 v/v) pumped at a flow rate 0.4 ml/min. The column temperature was maintained at 35 °C and the detector was monitored at a wavelength of 223 nm. The injection volume was 10 µl with a total run time of 3.5 min. The retention times of Formoterol fumarate and Fluticasone propionate was found to be 0.58±0.01 min and 1.84±0.01 min respectively. The calibration curves were linear in the concentration range of 3-9 µg/ml and 50-150 µg/ml of Formoterol fumarate and Fluticasone propionate respectively (r 2 = 0.999). The percentage recoveries were found to be 99.43-99.84 % for Formoterol fumarate and 99.44-100.51 % for Fluticasone propionate. The limit of detection was found to be 0.028 μg/ml & 0.15 μg/ml and limit of quantitation was found to be 0.085 μg/ml & 0.47 μg/ml for Formoterol fumarate and Fluticasone propionate respectively. The most sensitive UPLC method was developed for the estimation of dry powder inhalation containing varied strengths of Formoterol fumarate and Fluticasone propionate. The developed method was validated for system suitability, specificity, accuracy, precision, linearity, limit of detection, limit of quantitation and robustness according to International Conference on Harmonization (ICH) guidelines.

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Development and Validation of Ultra Performance Liquid Chromatographic Method for the Analysis of Pulmonary Drug Product Containing Formoterol Fumarate and Fluticasone Propionate

Chengalva¹,

Kuchana²

2018

Int. Res. J. Pharm.

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Development and Validation of RP-HPLC Method for Simultaneous Estimation of Tiotropium Bromide, Formoterol Fumarate, and Olodaterol HCl in Bulk and Metered Dose Aerosols: Application to Olodaterol HCl Forced Degradation Study and Degradation Kinetics

2017

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Method Development and Validation for Determining Formoterol Fumarate and Tiotropium in Tiomate Transcaps Dry Powder Inhaler

Gondhale

Cheriyan

2022

Pharm Chem J

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A validated spectrophotometric method for determination of formoterol fumarate dihydrate in bulk and dosage form using methyl orange as ion pair reagent

Cited by 8 publications

References 19 publications

Development and Validation of Ultra Performance Liquid Chromatographic Method for the Analysis of Pulmonary Drug Product Containing Formoterol Fumarate and Fluticasone Propionate

Development and Validation of Ultra Performance Liquid Chromatographic Method for the Analysis of Pulmonary Drug Product Containing Formoterol Fumarate and Fluticasone Propionate

Development and Validation of RP-HPLC Method for Simultaneous Estimation of Tiotropium Bromide, Formoterol Fumarate, and Olodaterol HCl in Bulk and Metered Dose Aerosols: Application to Olodaterol HCl Forced Degradation Study and Degradation Kinetics

Method Development and Validation for Determining Formoterol Fumarate and Tiotropium in Tiomate Transcaps Dry Powder Inhaler

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