Simultaneous spectrophotometric determination of indacaterol and glycopyrronium in a newly approved pharmaceutical formulation using different signal processing techniques of ratio spectra

Farouk, Maha; Hussein, Lobna A.; Magdy, Nancy; Yamani, Hend Z.

doi:10.1016/j.saa.2016.01.002

Cited by 16 publications

(2 citation statements)

References 17 publications

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“…Reviewing the literature survey, several methods were carried out for estimation of formoterol fumarate including spectrophotometry [6, 7], ultra performance liquid chromatography (UPLC) [8], gas chromatography mass spectrometric method (GC–MS) [9, 10], liquid chromatography [11–18], capillary electrophoresis [19–21]. Regarding, glycopyrronium bromide, few methods were described, including: UV [22, 23], conductometry [24], classical GC [25], HPLC [26–29], and advanced HPLC–MS methods [30, 31].…”

Section: Introductionmentioning

confidence: 99%

Multiple analytical methods for determination of formoterol and glycopyrronium simultaneously in their novel combined metered dose inhaler

et al. 2019

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One of the major causes of mortality all over the world is chronic obstructive pulmonary disease (COPD). Recently approved combined inhaler of formoterol fumarate (FF) and glycopyrronium bromide (GLY) has been used in very low concentrations (µg level/actuation) doses in COPD patients. The first spectrophotometric and advanced highly sensitive liquid chromatography has been achieved successfully throughout this study, permitting validated analysis of dual combined inhaler in raw material as well as pharmaceutical inhaled dosage form. Three sensitive analytical methods were carried out for the simultaneous assay of FF and GLY in their novel combined Metered dose inhaler (MDI). The first method depends on measuring the first derivative amplitudes at 208.27 nm for FF and at 213.27 nm and 239.86 nm for GLY, respectively. The second method depends on measurement of the first derivative of the ratio spectra at 214 or 229 nm for FF and 240 or 259 nm for GLY, respectively. For the spectrophotometric methods, the linearity ranges were 0.48–9.6 µg/mL for FF and 0.9–18 µg/mL for GLY. For the third method, valid ion-pairing chromatographic method was carried out applying C 18 column and isocratic mobile phase of 60% v/v acetonitrile and 40% v/v deionized waster (pH 3.0) enclosing 0.025% sodium dodecyl sulfate, using UV detection adjusted to 210 nm and flow rate of 1.2 mL/min. For the ion-pairing chromatographic method, the linearity ranges were 0.048–4.8 µg/mL for FF and 0.09–9.0 µg/mL for GLY. The developed methods are reproducible, valid and offer efficient resolution between formoterol and glycopyrronium using spectrophotometric methods and highly sensitive and precise chromatographic method. The percent recoveries of the inhaled drugs in their MDI were good. The method was successfully established for the quantitative analysis of FF and GLY in their combined pharmaceutical inhaler capsules to validate the therapeutic efficiency of the combined drugs in quality control labs. Electronic supplementary material The online version of this article (10.1186/s13065-019-0592-9) contains supplementary material, which is available to authorized users.

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Section: Introductionmentioning

confidence: 99%

Multiple analytical methods for determination of formoterol and glycopyrronium simultaneously in their novel combined metered dose inhaler

et al. 2019

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“…These methods include: spectrophotometry [5, 6], HPLC [7], GC [8], spectrofluorometry [5] and HPLC–MS methods [9–14]. IND is not cited in any pharmacopoeia while GLY is cited in European Pharmacopoeia (E.P.…”

Section: Introductionmentioning

confidence: 99%

Rapid simultaneous determination of indacaterol maleate and glycopyrronium bromide in inhaler capsules using a validated stability-indicating monolithic LC method

Zayed

Belal

2017

Chemistry Central Journal

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BackgroundChronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. A combination of indacaterol maleate with glycopyrronium bromide has recently been approved as a once-daily maintenance therapy in patients with COPD. The very low dose (μg level/capsule) renders the analysis of such products challenges. This study reports for the first time about HPLC method for the quality control of such combination and it is a stability indicating at the same time.ResultsA rapid, simple, precise and reproducible HPLC method was developed and validated for simultaneous determination of indacaterol maleate and glycopyrronium bromide using tenoxicam as an internal standard. The chromatographic separation was achieved on an onyx monolithic C18 column (100 × 4.6 mm) using a mobile phase consisting of acetonitrile and 30 mM phosphate buffer (pH 3.5) (30:70, v/v), run at a flow rate of 2 mL/min with UV detection at 210 nm. The total analysis time was less than 3 min. The HPLC method was validated for linearity, limits of detection and quantitation, precision, accuracy, system suitability and robustness. Calibration curves were obtained in the concentration ranges of 1–44 µg/mL for indacaterol maleate and 0.5–20 µg/mL for glycopyrronium bromide. Stability tests were done through exposure of the analyte solution for different stress conditions and the results indicate no interference of degradants with HPLC method.ConclusionsThe method was successfully applied for the quantitative analysis of indacaterol maleate and glycopyrronium bromide both individually and in a combined pharmaceutical inhaler capsules to support the quality control and to assure the therapeutic efficacy of the two drugs. The simple procedure involved in sample preparation and the short run-time added the important property of high throughput to the method. Graphical abstractChemical structures and representative HPLC chromatogram of indacaterol maleate (IND; 22 μg/mL), glycopyrronium bromide (GLY; 10 μg/mL) and tenoxicam (IS, 15μg/mL) in commercial capsules.

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TiO2 nanoparticles and ionic liquid platform for selective electrochemical determination of indacaterol in pharmaceutical formulations and human fluids: application to content uniformity

et al. 2019

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Simultaneous spectrophotometric determination of indacaterol and glycopyrronium in a newly approved pharmaceutical formulation using different signal processing techniques of ratio spectra

Cited by 16 publications

References 17 publications

Multiple analytical methods for determination of formoterol and glycopyrronium simultaneously in their novel combined metered dose inhaler

Multiple analytical methods for determination of formoterol and glycopyrronium simultaneously in their novel combined metered dose inhaler

Rapid simultaneous determination of indacaterol maleate and glycopyrronium bromide in inhaler capsules using a validated stability-indicating monolithic LC method

TiO2 nanoparticles and ionic liquid platform for selective electrochemical determination of indacaterol in pharmaceutical formulations and human fluids: application to content uniformity

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