Comparison of electrospray ionization mass spectrometry and evaporative light scattering detections for the determination of Poloxamer 188 in itraconazole injectable formulation

Nair, Lakshmy; Konkel, Jamie; Thomas, Mary J.; Koberda, Michael

doi:10.1016/j.jpba.2005.12.028

Cited by 15 publications

(15 citation statements)

References 12 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Other methods have also been applied to measure the surface PEG on PEGylated NPs, such as x-ray photoelectron spectroscopy (XPS) [241], anti-PEG antibody binding [242-245], and chromatographic measurements [246] [247]. XPS provides elemental information about the upper layer of the dried particles (~8-10 nm depth from the surface) with a significant error margin (~10 to 20%), and the PEG chains are in the collapsed status during XPS measurements.…”

Section: Methods For Nanoparticle Pegylation and Quantification Ofmentioning

confidence: 99%

“…Chromatographic methods can be used to quantify PEG content without modification or conjugation to a dye, though they are limited by sensitivity to contaminants, unstable baselines, and high detection limits when the RI detectors are used. The combination of evaporative light scattering detection and LC-MS was shown to have better sensitivity with less interference than an RI detector alone [247]. …”

Section: Methods For Nanoparticle Pegylation and Quantification Ofmentioning

confidence: 99%

See 1 more Smart Citation

PEGylation as a strategy for improving nanoparticle-based drug and gene delivery

Suk

Kim

et al. 2016

Advanced Drug Delivery Reviews

3,169

2,076

View full text Add to dashboard Cite

Coating the surface of nanoparticles with polyethylene glycol (PEG), or “PEGylation”, is a commonly used approach for improving the efficiency of drug and gene delivery to target cells and tissues. Building from the success of PEGylating proteins to improve systemic circulation time and decrease immunogenicity, the impact of PEG coatings on the fate of systemically administered nanoparticle formulations has, and continues to be, widely studied. PEG coatings on nanoparticles shield the surface from aggregation, opsonization, and phagocytosis, prolonging systemic circulation time. Here, we briefly describe the history of the development of PEGylated nanoparticle formulations for systemic administration, including how factors such as PEG molecular weight, PEG surface density, nanoparticle core properties, and repeated administration impact circulation time. A less frequently discussed topic, we then describe how PEG coatings on nanoparticles have also been utilized for overcoming various biological barriers to efficient drug and gene delivery associated with other modes of administration, ranging from gastrointestinal to ocular. Finally, we describe both methods for PEGylating nanoparticles and methods for characterizing PEG surface density, a key factor in the effectiveness of the PEG surface coating for improving drug and gene delivery.

show abstract

Section: Methods For Nanoparticle Pegylation and Quantification Ofmentioning

confidence: 99%

Section: Methods For Nanoparticle Pegylation and Quantification Ofmentioning

confidence: 99%

PEGylation as a strategy for improving nanoparticle-based drug and gene delivery

Suk

Kim

et al. 2016

Advanced Drug Delivery Reviews

3,169

2,076

View full text Add to dashboard Cite

show abstract

“…Some analytical methods have been reported for poloxamer quantification in pharmaceutical preparations (30)(31)(32), but despite their wide range of pharmaceutical applications and especially their recognized biological effect (21,22), limited analytical techniques have been developed for their quantification in biological matrices. We therefore decided to evaluate the applicability of 2D-COSY spectroscopy as a quantitative technique for poloxamers 188 and 407 in plasma.…”

Section: Applicationsmentioning

confidence: 99%

2D-Cosy NMR Spectroscopy as a Quantitative Tool in Biological Matrix: Application to Cyclodextrins

Dufour

Évrard

Tullio

2015

AAPS J

View full text Add to dashboard Cite

Abstract. Classical analytical quantifications in biological matrices require time-consuming sample pretreatments and extractions. Nuclear magnetic resonance (NMR) analysis does not require heavy sample treatments or extractions which therefore increases its accuracy in quantification. In this study, even if quantitative (q)NMR could not be applied to 2D spectra, we demonstrated that cross-correlations and diagonal peak intensities have a linear relationship with the analyzed pharmaceutical compound concentration. This work presents the validation process of a 2D-correlation spectroscopy (COSY) NMR quantification of 2-hydroxypropyl-β-cyclodextrin in plasma. Specificity, linearity, precision (repeatability and intermediate precision), trueness, limits of quantification (LOQs), and accuracy were used as validation criteria. 2D-NMR could therefore be used as a valuable and accurate analytical technique for the quantification of pharmaceutical compounds, including hardly detectable compounds such as cyclodextrins or poloxamers, in complex biological matrices based on a calibration curve approach.

show abstract

“…ELSD is much more sensitive over other techniques such as refractive index, and ELSD-based HPLC analytical methods can be easily transferred to liquid chromatographic mass spectroscopy (LCMS), as both methods employ compatible solvents (24). Besides the higher sensitivity (almost equivalent to that of liquid chromatography (LC) method) and solvent compatibility, the ELSD method has some additional advantages over other universal techniques (i.e., refractive index (RI) and LCMS) such as low cost and ease of operation.…”

Section: Introductionmentioning

confidence: 99%

“…While this method has several benefits, there are also some limitations such as low selectivity, requirement for volatile mobile phase, nonlinear response, and also being destructive to the sample (25). This detection method has been applied effectively for at least the last two decades to quantify a wide spectrum of natural and synthetic compounds including pharmaceuticals (i.e., drug molecules and excipients including polymers, sugars, lipids, and surfactants) (4,24,(26)(27)(28)(29), natural products and biologics (30,31). foods, and beverages (32,33).…”

Section: Introductionmentioning

confidence: 99%

Development of a Robust Method for Simultaneous Quantification of Polymer (HPMC) and Surfactant (Dodecyl β-D-Maltoside) in Nanosuspensions

Patel

Bummer

2015

AAPS PharmSciTech

View full text Add to dashboard Cite

Abstract. This report describes the development of a chromatographic method for the simultaneous quantification of a polymer, hydroxypropyl methylcellulose (HPMC), and a surfactant, dodecyl β-Dmaltoside (DM), that are commonly used in the physical stabilization of pharmaceutical formulations such as nanosuspensions and solid dispersions. These excipients are often challenging to quantify due to the lack of chromophores. A reverse phase size exclusion chromatography (SEC) with evaporative light scattering detector (ELSD) technique was utilized to develop an accurate and robust assay for the simultaneous quantification of HPMC and DM in a nanosuspension formulation. The statistical design of experiments was used to determine the influence of critical ELSD variables including temperature, pressure, and gain on accuracy, precision, and sensitivity of the assay. A robust design space was identified where it was determined that an increase in the temperature of the drift tube and gain of the instrument increased the accuracy and precision of the assay and a decrease in the nebulizer pressure value increased the sensitivity of the assay. In the optimized design space, response data showed that the assay could quantify HPMC and DM simultaneously with good accuracy, precision, and reproducibility. Overall, SEC-ELSD proved to be a powerful technique for the simultaneous quantification of HPMC and DM. This technique can be used to quantify the amount of HPMC and DM in nanosuspensions, which is critical to understanding their effects on the physical stability of nanosuspensions.KEY WORDS: design of experiments; dodecyl β-D-maltoside; evaporative light scattering detector; HPMC; nanosuspensions.

show abstract

Comparison of electrospray ionization mass spectrometry and evaporative light scattering detections for the determination of Poloxamer 188 in itraconazole injectable formulation

Cited by 15 publications

References 12 publications

PEGylation as a strategy for improving nanoparticle-based drug and gene delivery

PEGylation as a strategy for improving nanoparticle-based drug and gene delivery

2D-Cosy NMR Spectroscopy as a Quantitative Tool in Biological Matrix: Application to Cyclodextrins

Development of a Robust Method for Simultaneous Quantification of Polymer (HPMC) and Surfactant (Dodecyl β-D-Maltoside) in Nanosuspensions

Contact Info

Product

Resources

About