LC–MS/MS characterization of forced degradation products of zofenopril

Ramesh, T.; Rao, P. Nageswara; Rao, R. Nageswara

doi:10.1016/j.jpba.2013.10.018

Cited by 18 publications

(15 citation statements)

References 21 publications

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“…However, zofenopril is reported to reduce under alkaline hydrolytic condition (Figure 24). 85 For this, neither any mechanism is proposed in the report nor there any literature support. Hence, there is a need to analyze, and probably revise, the proposed route for formation of this product from zofenopril.…”

mentioning

confidence: 85%

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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confidence: 85%

Understanding unconventional routes to impurities from drugs in hydrolytic conditions

Kaur¹,

Bansal²,

Bansal³

2016

IJPER

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“…The accuracy of an analytical procedure expresses the closeness of agreement between the value which is accepted as a true value and the value found. It was determined by analyzing the known concentration of drug in spiked stressed sample (acidic hydrolysis), from the difference between peak areas of fortified and unfortified stressed samples (Ramesh, Rao, Rao, 2014;Patel et al, 2015). The experiment was performed in triplicate at three concentration levels (700, 1000 and 1300 ng mL -1 ), covering the range 70-130% of the test concentration (ICH, 1994).…”

Section: Methods Validationmentioning

confidence: 99%

Development and validation of a stability-indicating LC-UV and LC-MS/MS methods for quantitative analysis of anisomycin and identification of degradation products

Tolić¹,

Grujić

Laušević

2018

Braz. J. Pharm. Sci.

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Multifunctional drug anisomycin was subjected to forced degradation in accordance with International Conference on Harmonisation (ICH) guidelines for the first time. The drug was exposed to the recommended stress conditions of hydrolysis (acidic, alkaline and neutral), oxidation, thermal stress and photolysis, in order to investigate its stability. Optimized LC-MS/MS method was validated as recommended by ICH Q2(R1) guideline with respect to the specificity, accuracy, precision, limits of detection and quantitation, linearity and robustness. Anisomycin exhibited high instability under alkaline and thermal (neutral hydrolysis) conditions. It showed moderate stability under acidic, neutral, oxidative, thermal (acidic hydrolysis) and photolytic conditions, with the lowest degradation level observed in the case of light and oxidation stress. Formation of the same degradation product, identified as deacetylanisomycin, was observed under all applied stress conditions.

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“…Forced degradation studies are an important part of drug development, and are widely used to predict drug stability problems and identify degradation products or potential impurities. [2][3][4][5][6][7][8][9][10][11][12] When a drug degrades, it may result in the loss of drug activity and degradation products may elicit possible adverse reactions. Understanding the formation of degradation products is very important for defining product manufacturing conditions and choosing suitable packaging and storage conditions.…”

Section: Rationalementioning

confidence: 99%

Structural elucidation of stress degradation products of ampicillin sodium by liquid chromatography/hybrid triple quadrupole linear ion trap mass spectrometry and liquid chromatography/hybrid quadrupole time-of-flight mass spectrometry

et al. 2014

Rapid Commun. Mass Spectrom.

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LC–MS/MS characterization of forced degradation products of zofenopril

Cited by 18 publications

References 21 publications

Understanding unconventional routes to impurities from drugs in hydrolytic conditions

Understanding unconventional routes to impurities from drugs in hydrolytic conditions

Development and validation of a stability-indicating LC-UV and LC-MS/MS methods for quantitative analysis of anisomycin and identification of degradation products

Structural elucidation of stress degradation products of ampicillin sodium by liquid chromatography/hybrid triple quadrupole linear ion trap mass spectrometry and liquid chromatography/hybrid quadrupole time-of-flight mass spectrometry

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