Fesoterodine stress degradation behavior by liquid chromatography coupled to ultraviolet detection and electrospray ionization mass spectrometry

Sangoi, Maximiliano S.; Todeschini, Vítor; Steppe, Martin

doi:10.1016/j.talanta.2011.03.018

Cited by 23 publications

(11 citation statements)

References 32 publications

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“…The emphasis today is on techniques that allow characterization of very low quantities of degradation products instead of conventional processes of isolation and spectral analysis. The hyphenated techniques are considered for this purpose, among which LC‐MS tools have been explored more strongly due to their potential to directly characterize small quantities of degradation products 18, 19.…”

Section: Resultsmentioning

confidence: 99%

Determination of lumiracoxib by a validated stability‐indicating MEKC method and identification of its degradation products by LC‐ESI‐MS studies

Sangoi

Wrasse-Sangoi

Oliveira

et al. 2011

J of Separation Science

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A stability-indicating MEKC method was developed and validated for the analysis of lumiracoxib (LMC) in pharmaceutical formulations using nimesulide as the internal standard (IS). Optimal conditions for the separation of LMC and degradation products were investigated. The method employed 50 mM borate buffer and 50 mM anionic detergent SDS solution at pH 9.0. MEKC method was performed on a fused-silica capillary (50 μm id; effective length, 40 cm) maintained at 30°C. The applied voltage was 20 kV and photodiode array (PDA) detector was set at 208 nm. The method was validated in accordance with the International Conference on Harmonisation requirements. The stability-indicating capability of the method was established by enforced degradation studies combined with peak purity assessment using PDA detection. The degradation products formed under stressed conditions were investigated by LC-ESI-MS and the two degraded products were identified. MEKC method was linear over the concentration range of 5-150 μg/mL (r(2) =0.9999) of LMC. The method was precise, accurate, with LOD and LOQ of 1.34 and 4.48 μg/mL, respectively. The robustness was proved by a fractional factorial design evaluation. The proposed MEKC method was successfully applied for the quantitative analysis of LMC in tablets to support the quality control.

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Section: Resultsmentioning

confidence: 99%

Determination of lumiracoxib by a validated stability‐indicating MEKC method and identification of its degradation products by LC‐ESI‐MS studies

Sangoi

Wrasse-Sangoi

Oliveira

et al. 2011

J of Separation Science

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“…C-C bond cleavage: Cleavage of C-C bond is very improbable under hydrolytic conditions. Fesoterodine in acidic medium 49 and voriconazole in alkaline medium 119 are reported to degrade through this unusual reaction. Degradation of voriconazole due to C-C bond cleavage may be mechanized as outlined in Figure 8.…”

Section: 105mentioning

confidence: 94%

Understanding unconventional routes to impurities from drugs in hydrolytic conditions

Kaur¹,

Bansal²,

Bansal³

2016

IJPER

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Introduction: Hydrolytic degradation is the most common cause of formation of impurities or degradation products in drugs during different stages of drug product development and/or shelf life of the drug/product. Degradation products formed by hydrolysis of ester, amide, urethane, sulfonamide, sulfonate and ether linkages, and of nitrile, hydroxyl and amino groups in drugs can be conveniently predicted and identified. Many drugs are known to degrade to such expected conventional hydrolytic degradation products, and the mechanisms of such degradations are also well known and reported. However, many drugs are reported to degrade under hydrolytic conditions to products, which cannot be justified by the conventional hydrolytic reactions. Objectives: Though structures of such unconventional hydrolytic products can be characterized through different spectral techniques, but there is a need to understand the mechanisms of such unconventional hydrolytic reactions in order to help in establishing intrinsic stability characteristics of a drug. Methodology: In the present review, we have studied and critically analysed all possible reports on hydrolytic degradation of various dugs to provide a thorough insight into unconventional routes of hydrolytic degradations of drugs. The various unconventional hydrolytic reactions found responsible for degradation of drugs are classified as oxidation, dehydrogenation, coupling/condensation, N-alkylation, C-C bond cleavage, C-N bond cleavage, dehalogenation, cyclization, decarboxylation and hydroxylation. Discussion: Varied types of reactions under hydrolytic conditions are triggered/controlled by the nature of substituent(s) across or around the susceptible bonds/groups. The mechanisms for such unconventional hydrolytic reactions have been discussed or proposed with support from the standard literature. The contents are expected to enable an analyst and a drug formulator to predict various possible as well as seemingly improbable hydrolytic degradation products of a drug well ahead of systematic forced degradation studies.

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“…1d). A survey of chemical literature as shown that few articles are available for the determination of fesoterodine fumarate using LC and LC-MS [47][48][49], HPLC [50][51][52], UV [53][54][55] and electrophoresis [56]. An attempt has been made to develop a simple and rapid visible spectrophotometric method for the assay of selected drugs in tablet dosage forms.…”

Section: Introductionmentioning

confidence: 99%

Extractive-Spectrophotometric Determination of Some Antimuscarinic Antagonist in Tablet Formulations Using Eriochrome Cyanine R

El‐Didamony

Saad

Saleem

2018

Int J Pharm Pharm Sci

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Objective: To develop and validate simple, rapid and sensitive spectrophotometric method for the assay of four antimuscarinic antagonists, namely oxybutynin (OXB), solifenacin (SOL), tolterodine (TOL) and fesoterodine (FES) in bulk and pharmaceutical formulations.Methods: The proposed method is based on the reaction of the selected drugs with eriochrome cyanine R (ECR) in buffered aqueous solution at pH 1.0. The formed ion-pair complexes were extracted with dichloromethane and measured quantitatively with maximum absorption at 464 nm. All variables that affect on color intensity such as pH, buffer volume and concentration of ECR and extractive solvents were studied and optimized.Results: The calibration graphs were linear over the concentration range of 4–24, 4–32, 4–32 and 2–22 mg/ml for OXB, SOL, TOL and FES, respectively. The stoichiometry of the reaction was found to be 1:1 in all cases. Molar absorptivity values were found to be 2.043×104, 1.856×104, 1.798×104 and 2.856×104 l/mol/cm for OXB, SOL, TOL and FES, respectively. Excipients which used as an additive in commercial formulations did not interfere in the analysis.Conclusion: The developed method was successfully applied to determine OXB, SOL, TOL and FES in pharmaceutical preparations. The developed method can be used for quality control and routine analysis where time, cost effectiveness and high specificity of analytical technique are of great importance.

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Fesoterodine stress degradation behavior by liquid chromatography coupled to ultraviolet detection and electrospray ionization mass spectrometry

Cited by 23 publications

References 32 publications

Determination of lumiracoxib by a validated stability‐indicating MEKC method and identification of its degradation products by LC‐ESI‐MS studies

Determination of lumiracoxib by a validated stability‐indicating MEKC method and identification of its degradation products by LC‐ESI‐MS studies

Understanding unconventional routes to impurities from drugs in hydrolytic conditions

Extractive-Spectrophotometric Determination of Some Antimuscarinic Antagonist in Tablet Formulations Using Eriochrome Cyanine R

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