Determination of free and liposomal Amphotericin B in human plasma by liquid chromatography–mass spectroscopy with solid phase extraction and protein precipitation techniques

Deshpande, Niranjan M.; Gangrade, Manish; M.B.Kekare,; Vaidya, Vikas V.

doi:10.1016/j.jchromb.2009.11.036

Cited by 71 publications

(42 citation statements)

References 23 publications

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“…Analytical methods for the measurement of released and encapsulated drugs in plasma samples have previously been reported. However, these methods need complex sample preparation procedures, such as ultracentrifugation, 16) solid phase extraction (SPE), [17][18][19][20] gel filtration 17) or ultrafiltration 21) before analysis. These separation methods have a potential risk of sample deterioration: adsorption to ultrafiltration devices, high sample dilution during gel chromatography, and drug release from the liposomes during reversed phase SPE.…”

Section: Development Of Analytical Methods To Ensure the Quality Of Dmentioning

confidence: 99%

Development of Liposomal Anticancer Drugs

Hyôdô

Yamamoto

Suzuki

et al. 2013

Biological & Pharmaceutical Bulletin

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Liposomes are drug delivery systems that can alter the pharmacokinetic properties of compounds. The adverse effects of anticancer agents are a limiting factor for cancer chemotherapy, therefore, liposomal formulations have the potential to improve the therapeutic efficacy of anticancer agents by enhancing their accumulation in tumors and reducing non-selective distribution to normal tissues, which is known as the enhanced permeability and retention effect. To develop a liposomal anticancer agent as a drug product, its formulation must be designed to ensure its quality until it is administered to patients and to exert maximum potency in clinical use rather than in animal experiments. The chemical stability and physicochemical stability of the ingredients are key factors in the design of liposomal formulations. Drug release rates are critical factors in the therapeutic efficacy of liposomal drug products because the encapsulated drug has no pharmacological activity, and only released drug can exert antitumor/toxic activities. Liposomes should maintain the drug in a stable state in the circulation and then promptly release it after accumulation in the target tissue in order to achieve a sufficient drug concentration. To understand the profile of the formulation and to guarantee the quality of drug product, a reliable analytical method that can determine the released and encapsulated drugs in biological fluids is required. Simple online solid phase extractions of the released and encapsulated drugs using a column-switching HPLC system meet the requirements and this system enables accurate in vitro release testing and in vivo pharmacokinetic evaluation. This review introduces the process of liposomal drug product development from various viewpoints.

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Section: Development Of Analytical Methods To Ensure the Quality Of Dmentioning

confidence: 99%

Development of Liposomal Anticancer Drugs

Hyôdô

Yamamoto

Suzuki

et al. 2013

Biological & Pharmaceutical Bulletin

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“…Sample preparation for free AMP-B includes SPE while liposomal AMP-B is extracted by LLE from the SPE flow-through. The linear range is 0.27-16.23 mmol/L (0.25-15.0 mg/mL) and the CV is 1.4-6.3% for free AMP-B, while 1.08-108.22 mmol/L (1.0-100.0 mg/mL) and 4.0-8.9% for liposomal AMP-B, respectively [15]. [7,8], plasma [5,6,8] Chromolith Performance RP-18e (100 Â 4.6 mm) [5,6,8], Chromolith (50 Â 4.6 mm) [7] Clobazam, N-desmethylclobazam [5] lamotrigine [7,8], phenytoin [8], carbamazepine-10,11-expoide [8], felbamate [8], dihydro-10-hydroxycarbamazepine [8], phentobarbital [8], phenobarbital [8], carbamazepine [8], primidone [8], zonisamide [8] [ [9,10,15,20] Plasma [9, 10, 13-15, 17, 20], serum [12], CSF [14], dried blood spots [16], urine [12,18], whole blood [19] Chromolith C18 (100 Â 4.6 mm) [9], Chromolith Performance RP-18e (100 Â 4.6 mm) [10,[13][14][15],…”

Section: Antibiotics Antiviral Antifungal and Antimalarial Drugsmentioning

confidence: 96%

“…Therefore, patients are monitored during the intravenous delivery to determine the amount of free and liposomal AMP-B. Plasma AMP-B was separated on a monolithic column in 6.5 min and was detected by LC-MS/MS [15]. Sample preparation for free AMP-B includes SPE while liposomal AMP-B is extracted by LLE from the SPE flow-through.…”

Section: Antibiotics Antiviral Antifungal and Antimalarial Drugsmentioning

confidence: 99%

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Applications of monolithic columns in liquid chromatography‐based clinical chemistry assays

Bunch

Wang

2011

J of Separation Science

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Monolithic columns have slowly been applied to HPLC methods for clinical chemistry testing in the last 10 years. The application areas include therapeutic drug monitoring, drugs of abuse, vitamins, porphyrins, and steroids. In comparison with conventional particulate columns, the monolithic columns may offer shorter chromatography time, more robustness, and better resolution for certain analytes. The potential drawback of large mobile phase consumption may be improved with smaller id columns, which are currently on the market. Methods covered in this review are those searchable in PubMed up to December 2010. This review highlights the emergence of monolithic column technology in HPLC methods used for clinical chemistry testing. The goals of this review are threefold: (i) To identify the areas of clinical chemistry that analytical monolithic columns have been used in HPLC methods. (ii) To demonstrate the application of analytical monolithic columns in HPLC methods using different detection systems. (iii) To discuss the advantages and limitations of the monolithic columns compared with particulate columns in the clinical chemistry applications.

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“…With the purpose of defining the drug content of nanoparticles, a quantitation method must be appropriately validated. Various methods have been described in the literature for determining the AmB content in samples, such as the use of biological matrices, high performance liquid chromatography (HPLC) (Italia, Singh, Kumar, 2009;Espada et al, 2008;Eldem, Arican-Cellat, 2001), second-derivative spectrophotometry (Ganière Monteil et al, 1998), and liquid chromatography tandem mass spectrometry (LC-MS/MS) (Deshpande et al, 2010). In lipid formulations, HPLC (Manosroi, Kongkaneramit, Manosroi, 2004a;Manosroi, Kongkaneramit, Manosroi, 2004b;Eldem, Arican-Cellat, 2000) and UV/Vis-spectrophotometry (Legrand et al, 1997;Larabi et al, 2004;Jung et al, 2009) have been reported.…”

Section: Introductionmentioning

confidence: 99%

Determination of amphotericin B in PLA-PEG blend nanoparticles by HPLC-PDA

Rodrigues¹,

Khalil²,

Mainardes³

2014

Braz. J. Pharm. Sci.

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In this work, we developed and validated an effective reversed-phase HPLC method with photodiode array (PDA) detection for the quantitative analysis of amphotericin B (AmB) in poly(lactide)-poly(ethylene glycol) (PLA-PEG) blend nanoparticles. Chromatographic runs were performed on a reverse phase C18 column using a mobile phase comprising a 9% acetic acid and acetonitrile mixture (40:60, v/v) under isocratic elution with a flow rate of 1 mL/min. AmB was detected at a wavelength of 408 nm. The validation process was performed considering the selectivity, linearity, precision, accuracy, robustness, limit of detection (LOD) and limit of quantitation (LOQ) of the method. A concentration range of 1-20 µg/mL was used to construct a linear calibration curve. The LOQ and LOD were 55 and 18 ng/mL, respectively. The mean recovery of AmB from the samples was 99.92% (relative standard deviation (RSD) = 0.34%, n=9), and the method was robust for changes in the flow rate of the mobile phase (maximum RSD=4.82%). The intra-and inter-assay coefficients of variation were less than 0.59%. The method was successfully used to determine the entrapment efficiency of AmB in PLA-PEG blend nanoparticles.Uniterms: Amphotericin B/determination. Amphotericin B/encapsulation. High performance liquid chromatography/reverse phase/quantitative analysis. Nanoparticles.Neste trabalho desenvolveu-se e validou-se um efetivo método por cromatografia líquida de alta eficiência (CLAE) em fase reversa com detecção por fotodiodos para a análise quantitativa de anfotericina B (AmB) em nanopartículas compostas por blendas de poli(ácido lático)-polietilenoglicol (PLA-PEG). Corridas cromatográficas foram realizadas sob coluna C18 de fase reversa com fase móvel consistindo de ácido acético 9% e acetonitrila (40:60, v/v), em eluição isocrática com fluxo de 1 mL/min. A AmB foi detectada no comprimento de onda de 408 nm. O processo de validação foi realizado considerando a seletividade, linearidade, precisão, exatidão, robustez, limite de detecção (LD) e limite de quantificação (LQ) do método. Uma faixa de concentração entre 1-20 µg/mL foi usada para obter a curva-padrão linear. Os valores de LD e LQ foram 55 e 18 ng/mL, respectivamente. A recuperação média da AmB a partir das amostras foi de 99,92% (desvio padrão relativo = 0,34%, n=9) e o método foi robusto, considerando alterações no fluxo da fase móvel (desvio padrão relativo máximo=4,82%). Os coeficientes de variação intra e inter dia foram inferiores a 0,59%. O método foi utilizado com sucesso para a determinação da eficiência de encapsulação da AmB em nanopartículas de PLA-PEG.Unitermos: Anfotericina B/determinação. Anfotericina B/encapsulação em nanopartículas. Cromatografia líquida de alta eficiência/fase reversa. Nanopartículas.

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Determination of free and liposomal Amphotericin B in human plasma by liquid chromatography–mass spectroscopy with solid phase extraction and protein precipitation techniques

Cited by 71 publications

References 23 publications

Development of Liposomal Anticancer Drugs

Development of Liposomal Anticancer Drugs

Applications of monolithic columns in liquid chromatography‐based clinical chemistry assays

Determination of amphotericin B in PLA-PEG blend nanoparticles by HPLC-PDA

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