Identification of unknown impurities in simvastatin substance and tablets by liquid chromatography/tandem mass spectrometry

Vuletić, Marko; Cindrić, Mario; Koružnjak, Jasna Dogan

doi:10.1016/j.jpba.2004.11.047

Cited by 37 publications

(22 citation statements)

References 13 publications

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“…, m/z 419) is studied in detail using triple-quadrupole, ion-trap and Q-TOF instruments (Wang, Wu, & Zhao, 2001;Vuletić, Cindrić, & Koruznjak, 2005) (Wang, Wu, & Zhao, 2001), although an alternative structure has been suggested, involving a cleavage of the C-C bond at the hexahydronaphthalene ring with charge retention at the lactone ring (C 7 H 11 O 3 þ ; see Scheme 24). Interestingly, accurate-mass data indicate that both structure are observed, that is, the ion with C 7 H 11 O 3 þ at low collision energy, and the ion with C 11 H 11 þ at higher collision energy, which is in agreement with expectation based on the fragmentation pathways of both ions.…”

Section: Statinsmentioning

confidence: 99%

Fragmentation of toxicologically relevant drugs in positive‐ion liquid chromatography–tandem mass spectrometry

Niessen¹

2011

Mass Spectrometry Reviews

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The identification of drugs and related compounds by LC-MS-MS is an important analytical challenge in several application areas, including clinical and forensic toxicology, doping control analysis, and environmental analysis. Although target-compound based analytical strategies are most frequently applied, at some point the information content of the MS-MS spectra becomes relevant. In this article, the positive-ion MS-MS spectra of a wide variety of drugs and related substances are discussed. Starting point was an MS-MS mass spectral library of toxicologically relevant compounds, available on the internet. The positive-ion MS-MS spectra of ∼570 compounds were interpreted by chemical and therapeutic class, thus involving a wide variety of drug compound classes, such benzodiazepines, beta-blockers, angiotensin-converting enzyme inhibitors, phenothiazines, dihydropyridine calcium channel blockers, diuretics, local anesthetics, vasodilators, as well as various subclasses of anti-diabetic, antidepressant, analgesic, and antihistaminic drugs. In addition, the scientific literature was searched for available MS-MS data of these compound classes and the interpretation thereof. The results of this elaborate study are presented in this article. For each individual compound class, the emphasis is on class-specific fragmentation, as discussing fragmentation of all individual compounds would take far too much space. The recognition of class-specific fragmentation may be quite informative in determining the compound class of a specific unknown, which may further help in the identification. In addition, knowledge on (class-specific) fragmentation may further help in the optimization of the selectivity in targeted analytical approaches of compounds of one particular class.

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Section: Statinsmentioning

confidence: 99%

Fragmentation of toxicologically relevant drugs in positive‐ion liquid chromatography–tandem mass spectrometry

Niessen¹

2011

Mass Spectrometry Reviews

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“…[21][22][23]27 However, C8 has been chosen because separation shows a slightly lower peak retention time (t R…”

Section: Resultsmentioning

confidence: 99%

“…20,21 Furthermore, LC-MS/MS was employed to identify SIM impurities or degradation products in bulk drug or tablets dosage form. 22,23 UV spectrometry, LC-UV and LC-MS have been reported to quantify SIM associated with other drugs such as ezetimibe, gemfibrozile or in multi-drugs formulation. [24][25][26][27] A micellar electrokinetic chromatographic (MEKC) method has been employed to quantify SIM and LOV in tablets.…”

Section: Introductionmentioning

confidence: 99%

“…Acetonitrile (ACN) widely used in combination with buffer solution in mobile phases, mainly in SIM official monographs of solid dosage forms. 2,11,12,14,15,18,20,22,23,[25][26][27]29 Methanol in a binary mobile phase has been reported for SIM determination in nanoparticles (specific pharmaceutical dosage form) in the concentration range 20-80 mg mL -1 . ACN worldwide shortage has reached a very high cost in the market between years 2008 and 2009.…”

Section: Introductionmentioning

confidence: 99%

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Simvastatin assay and dissolution studies by feasible RP-HPLC in tablets

Marques-Marinho¹,

Santos²,

Vianna-Soares³

et al. 2012

Quím. Nova

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Recebido em 19/9/11; aceito em 10/12/11; publicado na web em 23/3/12Commonly used HPLC acetonitrile solvent has been through a worldwide shortage with a cost increase in 2008 and 2009. In order to get around this situation, a method by RP-HPLC employing methanol and aqueous acid mobile phase was developed and validated to evaluate simvastatin. The quality control assay and dissolution studies of this lipid-lowering drug were performed in diluents methanol and 0.01 M phosphate buffer with 0.5% SDS, pH 7, respectively. Dissolution test aliquots did not go through sample treatment, as described in USP SIM tablets monograph by ultraviolet spectrophotometry. The proposed method is fast, simple, feasible and robust.

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“…This ensures that drug metabolism, safety and clinical studies are not jeopardized by inconsistent purity or impurities having potential harmful toxological properties. Regulatory guidelines promulgated by the International Conference on Harmonization (ICH) dictates rigorous identification of impurities at levels of 0.1% and greater depending upon dosage, followed by appropriate toxicological studies, if needed, for qualification [4].…”

Section: Introductionmentioning

confidence: 99%

LCMS using a hybrid quadrupole time of flight mass spectrometer for impurity identification during process chemical development of a novel integrase inhibitor

Novak

Grinberg

Hartman

et al. 2010

Journal of Pharmaceutical and Biomedical Analysis

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Identification of unknown impurities in simvastatin substance and tablets by liquid chromatography/tandem mass spectrometry

Cited by 37 publications

References 13 publications

Fragmentation of toxicologically relevant drugs in positive‐ion liquid chromatography–tandem mass spectrometry

Fragmentation of toxicologically relevant drugs in positive‐ion liquid chromatography–tandem mass spectrometry

Simvastatin assay and dissolution studies by feasible RP-HPLC in tablets

LCMS using a hybrid quadrupole time of flight mass spectrometer for impurity identification during process chemical development of a novel integrase inhibitor

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