Overview: Isolation and characterization of impurities

Ahuja, Satinder

doi:10.1016/s0149-6395(03)80003-x

Cited by 43 publications

(31 citation statements)

References 5 publications

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“…This finding suggests that crospovidone is incompatible with VAL under these conditions (high humidity and temperature). In previous reports (Ahuja et al, 2003) crospovidone, a cross-linked modified polyvinylpyrrolidone (PVP), was incompatible with several APIs, due to generation of hydrogen peroxide (Yue et al, 2009;Wu et al, 2011). Peroxides are reactive substances present in various excipients that can initiate radical chain reactions or react directly with drugs, inducing the formation of degradation products.…”

Section: Stability and Compatibility Assaymentioning

confidence: 99%

Compatibility and stability of valsartan in a solid pharmaceutical formulation

Julio

Zâmara

Garcia

et al. 2013

Braz. J. Pharm. Sci.

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Valsartan (VAL) is a highly selective blocker of the angiotensin II receptor that has been widely used in the treatment of hypertension. Active pharmaceutical ingredient compatibility with excipients (crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose and titanium dioxide) is usually evaluated in solid pharmaceutical development. Compatibility and stability can be evaluated by liquid chromatography. Studies were performed using binary mixtures of 1:1 (w/w) VAL/excipient; samples were stored under accelerated stability test conditions (40 °C at 75% relative humidity). The results indicate that VAL is incompatible with crospovidone and hypromellose, which reduced the VAL content and gave rise to new peaks in the chromatogram due to degradation products. Valsartana (VAL) é um bloqueador altamente seletivo do receptor da angiotensina II, que tem sido amplamente utilizado para o tratamento da hipertensão. Testes de compatibilidade com excipientes usualmente empregados em formulações sólidas são utilizados no desenvolvimento de formulações sólidas. Neste trabalho, realizaram-se testes utilizando misturas binárias na proporção 1:1 (m/m) de VAL/excipiente e as amostras foram armazenadas em condições de estabilidade acelerada (40 °C em 75% de umidade relativa). Os resultados obtidos indicam a incompatibilidade de VAL com crospovidona e hipromelose, através da redução do teor de VAL e a presença de novos picos no cromatograma provenientes de produtos de degradação.Unitermos: Valsartana/compatibilidade. Valtasan/estabilidade. Hipertensão/tratamento. Calorimetria Exploratória Diferencial/análise de fármacos. Cromatografia líquida de alto desempenho/análise quantitativa.

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Section: Stability and Compatibility Assaymentioning

confidence: 99%

Compatibility and stability of valsartan in a solid pharmaceutical formulation

Julio

Zâmara

Garcia

et al. 2013

Braz. J. Pharm. Sci.

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“…An example is the reaction between cycloserine and hydrogen peroxide (which is an impurity of crospovidone) [10]. Deterministic reaction prediction works well for cases where the chemistry is sufficiently understood.…”

Section: Deterministic Reaction Predictionmentioning

confidence: 99%

Purdue Ontology for Pharmaceutical Engineering: Part II. Applications

Hailemariam

Venkatasubramanian

2010

J Pharm Innov

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The multiple steps in pharmaceutical product development generate a large amount of diverse information in various formats, which hinders efficient decisionmaking. A major component of the solution is a common information model for the domain. Ontologies were found to meet this need as described in Part I of this two-part paper. In Part II, we describe two applications of Purdue Ontology for Pharmaceutical Engineering. The first application deals with the prediction of degradation reactions through incorporation of molecular structure and environmental information captured in the ontologies. The second application is one that analyzes experiments to identify differences in experimental implementation.

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“…The stability testing can used to optimize for the appropriate packing process, determining storage conditions, shelf life and expiry date. [8][9][10][11][12][13] These reasons warrant the need of method for assessing the quality control (QC) of PAZ-containing tablets.…”

Section: Introductionmentioning

confidence: 99%

ICH guidelines-compliant HPLC-UV method for pharmaceutical quality control and therapeutic drug monitoring of the multi-targeted tyrosine kinase inhibitor pazopanib

et al. 2017

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In this study, an HPLC method with ultraviolet (UV) detection was developed and validated for determination of pazopanib (PAZ), a multi-targeted tyrosine kinase (TK) inhibitor in bulk drug, tablets formulation, and in human plasma. Oxamniquine (OXA) was used as internal standard (IS). The analytical column used for the separation was Nucleosil CN with dimensions (i.d. 250 × 4.6 mm and particle size 5 µm). The separation was carried out in isocratic mode with mobile phase constituting acetonitrile:100 mM sodium acetate buffer (pH 4. KEYWORDSTyrosine kinase inhibitors, pazopanib, HPLC, UV detection, quality control, therapeutic drug monitoring. IntroductionAn important role of vascular endothelial growth factor receptor (VEGF) in quite a few tumor forms has been reported.1-3 The dysregulation of platelet derived growth factor (PDGF) 4 and epidermal growth factor (EGF) 5 also play an important role in propagation of tumor cell. Pazopanib (PAZ; GW-786034) chemically known as 5-({4-[(2,3-Dimethyl-2H-indazol-6-yl) (methyl) amino]-2-pyrimidinyl}amino)-2-methylbenzene-sulfonamide (Fig. 1) is tyrosine kinase inhibitor (multi-targeted and orally active). The targets for PAZ are VEGFR-1, -2, and -3, PDGFR-a, PDGFR-b, c-Kit and act by inhibiting auto-phosphorylation of growth factor receptor (intracellular TK domain). PAZ competes with ATP to bind to the intracellular TK domain thus, blocking downstream signal transduction. 6 The recommended dose of PAZ is not more than 800 mg once daily for treatment of soft tissue sarcoma or renal cell carcinoma. Pharmacokinetic studies have revealed peak plasma concentration of 58.1 µg mL -1 and mean AUC of 1037 µg h mL -1 for PAZ after a dose of 50-2000 mg. The absorption of PAZ in cancer patients is slow and the bioavailability of 800 mg tablet in these patients is 21 %. The PAZ accumulates after continuous once daily dosing for 22 days and the drug is present in the systemic circulation as intact PAZ and not as metabolites of PAZ. PAZ is 99 % plasma protein bound and is eliminated mainly through feces and around 4 % through renal route.

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Overview: Isolation and characterization of impurities

Cited by 43 publications

References 5 publications

Compatibility and stability of valsartan in a solid pharmaceutical formulation

Compatibility and stability of valsartan in a solid pharmaceutical formulation

Purdue Ontology for Pharmaceutical Engineering: Part II. Applications

ICH guidelines-compliant HPLC-UV method for pharmaceutical quality control and therapeutic drug monitoring of the multi-targeted tyrosine kinase inhibitor pazopanib

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