Development and validation of stability indicating chromatographic method for determination of impurities in maprotiline pharmaceutical tablets

Đurić, Svetlana Lj.; Nasković, Daniela Č.; Veličković, Dragan T.; Milenović, Dragan M.

doi:10.1134/s1061934815020197

Cited by 4 publications

(7 citation statements)

References 15 publications

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“…Bupropion (Bansal et al 2013 ) and dosulepin (Reddy et al 2014 ) are unstable under ICH conditions. Photostability of maprotiline was investigated under doubled ICH conditions (400 W m −2 and 2.4 * 10 6 lx h, the drug was unstable) (Đurić et al 2015 ). Venlafaxine under UV radiation was almost stable (3.95 % of the substance decomposed after 10 h of irradiation) (Rao et al 2015 ).…”

Section: Photostability Testing Of Drugsmentioning

confidence: 99%

Studies on photodegradation process of psychotropic drugs: a review

Trawiński

Skibiński

2016

Environ Sci Pollut Res

109

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Consumption of psychotropic drugs is still increasing, especially in high-income countries. One of the most crucial consequences of this fact is significant release of them to the environment. Considerable amounts of atypical antipsychotics, benzodiazepines, antidepressants, and their metabolites were detected in river, lake, and sea water, as well as in tissues of aquatic organisms. Their ecotoxicity was proved by numerous studies. It should be noticed that interaction between psychotropic pharmaceuticals and radiation may lead to formation of potentially more toxic intermediates. On the other hand, photo-assisted wastewater treatment methods can be used as an efficient way to eliminate them from the environment. Many methods based on photolysis and photocatalysis were proposed and developed recently; nevertheless, the problem is still unsolved. However, according to recent studies, photocatalysis could be considered as the most promising and far more effective than regular photolysis. An overview on photolytic as well as homogenous and heterogeneous photocatalytic degradation methods with the use of various catalysts is presented. The photostability and phototoxicity of pharmaceuticals were also discussed. Various analytical methods were used for the photodegradation research, and this issue was also compared and summarized. Use of high-resolution multistage mass spectrometry (Q-TOF, ion trap, Orbitrap) was suggested. The combined techniques such as LC–MS, GC–MS, and LC–NMR, which enable qualitative and quantitative analyses in one run, proved to be the most valuable in this case. Assembling of MS/MS spectra libraries of drug molecules and their phototransformation products was identified as the future challenge.

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Section: Photostability Testing Of Drugsmentioning

confidence: 99%

Studies on photodegradation process of psychotropic drugs: a review

Trawiński

Skibiński

2016

Environ Sci Pollut Res

109

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“…As first-line treatment options for mental health disorders, their stability and integrity are essential for maximum efficiency; however, the therapeutic properties of antidepressants can be compromised due to various degradation pathways, including thermal degradation, hydrolysis (forced hydrolysis, extreme pH hydrolysis), oxidation, and photodegradation [69,70]. Understanding the details of degradation processes is essential for ensuring the efficacy, safety, and shelf life of these medications [35,[71][72][73].…”

Section: Overview Of Antidepressant Drug Degradationmentioning

confidence: 99%

“…Scientists have identified various chemical degradation pathways that antidepressant medications may undergo, with potential loss of their efficacy. This can help researchers design more stable and effective drug formulations [72,89,90].…”

Section: Degradation Pathways For Antidepressant Drugsmentioning

confidence: 99%

“…Additionally, specific drug-drug interactions may accelerate degradation, especially when antidepressants are co-administered with other medications. Proper knowledge of degradation pathways for antidepressants can guide the development of suitable storage conditions and packaging materials shielding the drugs from environmental factors inducing degradation [72,94].…”

Section: Degradation Pathways For Antidepressant Drugsmentioning

confidence: 99%

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An Overview of Degradation Strategies for Amitriptyline

Comanescu,

Racovita

2024

IJMS

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Antidepressant drugs play a crucial role in the treatment of mental health disorders, but their efficacy and safety can be compromised by drug degradation. Recent reports point to several drugs found in concentrations ranging from the limit of detection (LOD) to hundreds of ng/L in wastewater plants around the globe; hence, antidepressants can be considered emerging pollutants with potential consequences for human health and wellbeing. Understanding and implementing effective degradation strategies are essential not only to ensure the stability and potency of these medications but also for their safe disposal in line with current environment remediation goals. This review provides an overview of degradation pathways for amitriptyline, a typical tricyclic antidepressant drug, by exploring chemical routes such as oxidation, hydrolysis, and photodegradation. Connex issues such as stability-enhancing approaches through formulation and packaging considerations, regulatory guidelines, and quality control measures are also briefly noted. Specific case studies of amitriptyline degradation pathways forecast the future perspectives and challenges in this field, helping researchers and pharmaceutical manufacturers to provide guidelines for the most effective degradation pathways employed for minimal environmental impact.

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“…Therefore, the expected unmetabolized concentration of MAP in human urine is 8.1 × 10 −6 to 2.2 × 10 −5 mol L −1 . The importance of its use in human treatment has led to the development of a variety of analytical methods for its determination, including high-performance liquid chromatography [ 18 ], liquid chromatography [ 19 , 20 ], reversed-phase ultra-fast liquid chromatography [ 21 ], either high [ 22 ] or ultra-high [ 23 ] performance liquid chromatography coupled to mass spectrometry with supported liquid extraction, either gas or gas-liquid chromatography coupled to mass spectroscopy, capillary electrophoresis, and spectrophotometry [ 24 ].…”

Section: Introductionmentioning

confidence: 99%

Potentiometric Determination of Maprotiline Hydrochloride in Pharmaceutical and Biological Matrices Using a Novel Modified Carbon Paste Electrode

Radić

Perović

Gričar

et al. 2022

Sensors

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Potentiometry with membrane selective electrodes is preferable for measuring the various constituents of pharmaceuticals. In this work, carbon paste electrodes (CPE) were prepared, modified, and tested for the determination of maprotiline hydrochloride, which acts as an antidepressant. The proposed CPE was based on an ionic association complex of maprotiline-tetraphenylborate, 2-nitrophenyloctyl as a binder, and sodium tetraphenylborate as an ionic lipophilic additive. The optimized composition improved potentiometric properties up to theoretical Nernst response values of −59.5 ± 0.8 mV dec−1, in the concentration range of maprotiline from 1.6 × 10−7 to 1.0 × 10−2 mol L−1, and a detection limit of 1.1 × 10−7 mol L−1. The CPE provides excellent reversibility and reproducibility, exhibits a fast response time, and is applicable over a wide pH range. No significant effect was observed in several interfering species tested. The proposed electrode was used for the precise determination of maprotiline in pure solutions, urine samples, and a real sample—the drug Ludiomil.

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Development and validation of stability indicating chromatographic method for determination of impurities in maprotiline pharmaceutical tablets

Cited by 4 publications

References 15 publications

Studies on photodegradation process of psychotropic drugs: a review

Studies on photodegradation process of psychotropic drugs: a review

An Overview of Degradation Strategies for Amitriptyline

Potentiometric Determination of Maprotiline Hydrochloride in Pharmaceutical and Biological Matrices Using a Novel Modified Carbon Paste Electrode

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