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

Elkady, Ehab F.; Tammam, Marwa Hosny; Elmaaty, Ayman Abo

doi:10.1007/s10337-017-3413-0

Cited by 6 publications

(2 citation statements)

References 16 publications

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“…To calculate the extraction rate of the collecting filter, 1 actuation (2.5 ug) of tiotropium was delivered to the filter and eluted using 10 mL of an acid sodium salt solvent [9]. The drug dose was analyzed using high-performance liquid chromatography (HPLC), and the extraction rate of the filter was 95%.…”

Section: Drug Elution and Analysis Of Tiotropiummentioning

confidence: 99%

Optimal Connection for Tiotropium SMI Delivery through Mechanical Ventilation: An In Vitro Study

et al. 2020

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We aimed to quantify Soft Mist Inhalers (SMI) delivery to spontaneous breathing model and compare with different adapters via endotracheal tube during mechanical ventilation or by manual resuscitation. A tiotropium SMI was used with a commercial in-line adapter and a T-adapter placed between the Y-adapter and the inspiratory limb of the ventilator circuit during mechanical ventilation. The SMI was actuated at the beginning of inspiration and expiration. In separate experiments, a manual resuscitator with T-adapter was attached to endotracheal tube, collecting filter, and a passive test lung. Drug was eluted from collecting filters with salt-based solvent and analyzed using high-performance liquid chromatography. Results showed the percent of SMI label dose inhaled was 3-fold higher with the commercial in-line adapter with actuation during expiration than when synchronized with inspiration. SMI with T-adapter delivery via ventilator was similar to inhalation (1.20%) or exhalation (1.02%), and both had lower delivery dose than with manual resuscitator (2.80%; p = 0.01). The inhaled dose via endotracheal tube was much lower than inhaled dose with spontaneous breathing (22.08%). In conclusion, the inhaled dose with the commercial adapter was higher with SMI actuated during expiration, but still far less than reported spontaneous inhaled dose.

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Section: Drug Elution and Analysis Of Tiotropiummentioning

confidence: 99%

Optimal Connection for Tiotropium SMI Delivery through Mechanical Ventilation: An In Vitro Study

et al. 2020

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“…In the literature research, it is observed that there are studies including different analytical techniques, mostly assay. RP-HPLC systems used in inhaler products [6][7][8]11 and liquid chromatography triple-quadrupole (LC-MS) methods used especially for determinations in human plasma 1,12 are generally studied for the Tiotropium Bromide assay. In the literature research conducted for the determination of Tiotropium Bromide impurities, no methods other than RP-HPLC were found, and it was seen that known impurities were not defined in these studies.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous quantification of tiotropium bromide impurities G + H in capsule formulation by LC-MS/MS

Erkol,

Güleli,

Çalışkan

et al. 2023

Eur J Mass Spectrom (Chichester)

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Tiotropium Bromide is a long-acting bronchodilator that is used in the treatment of chronic obstructive pulmonary disease (COPD) and asthma bronchodilator or bronchiolitis, which are substances that expand the bronchi and reduce resistance in the respiratory tract and increase airflow to the lungs. For Tiotropium Bromide found in inhaler capsules to treat COPD, determining the relevant impurities G and H, which are not UV active, is crucial. For this purpose, a new and sensitive liquid chromatography triple-quadrupole mass spectrometry (LC-MS/MS) detection with electrospray ionization by using multiple reaction monitoring in the positive mode method was developed and validated. The identity of the compounds was supported by using LC-Q/TOF. All chromatographic studies were performed with a Zorbax Eclipse XDB-C8 (150 mm x 4.6 mm, 5.0 µm) column with a total injection time of 13 min at a flow rate of 0.4 ml/min as a gradient. The limit of detection (LOD) and limit of quantitation (LOQ) in the current study range were determined as 1.0 ppb and 2.5 ppb, respectively. The results of the validation parameters following the ICH Q2(R1) guideline were determined within the acceptance criteria.

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A semi-covalent molecularly imprinted electrochemical sensor for rapid and selective detection of tiotropium bromide

Çetinkaya

Kaya

Atici³

et al. 2022

Anal Bioanal Chem

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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

Cited by 6 publications

References 16 publications

Optimal Connection for Tiotropium SMI Delivery through Mechanical Ventilation: An In Vitro Study

Optimal Connection for Tiotropium SMI Delivery through Mechanical Ventilation: An In Vitro Study

Simultaneous quantification of tiotropium bromide impurities G + H in capsule formulation by LC-MS/MS

A semi-covalent molecularly imprinted electrochemical sensor for rapid and selective detection of tiotropium bromide

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