determining-four-components-lipid-nanoparticle-rna-delivery-system

Determining Four Components in a Lipid Nanoparticle RNA Delivery System by Liquid Chromatography Combined with Evaporative Light Scattering Detector

This article presents a method for the analysis of lipid nanoparticle (LNP) components. LNP, serving as a pivotal vector for RNA-based drugs, primarily ...

Shimadzu (China) Co., Ltd.

Semen sojae praeparatum with homology of medicine and food is a famous traditional Chinese medicine. A simple and effective quality fingerprint analysis, coupled with chemometrics methods, was developed for quality assessment of Semen sojae praeparatum. First, similarity analysis (SA) and hierarchical clusting analysis (HCA) were applied to select the qualitative markers, which obviously influence the quality of Semen sojae praeparatum. 21 chemicals were selected and characterized by high resolution ion trap/time-of-flight mass spectrometry (LC-IT-TOF-MS). Subsequently, principal components analysis (PCA) and orthogonal partial least squares discriminant analysis (OPLS-DA) were conducted to select the quantitative markers of Semen sojae praeparatum samples from different origins. Moreover, 11 compounds with statistical significance were determined quantitatively, which provided an accurate and informative data for quality evaluation. This study proposes a new strategy for "statistic analysis-based fingerprint establishment", which would be a valuable reference for further study.

A new strategy for statistical analysis-based fingerprint establishment: Application to quality assessment of Semen sojae praeparatum.

The isoflavones widely exist in the daily diets and interferences are usually inevitable in the determination of the in vivo level of the same analytes. A new strategy to eliminate the dietary interference was established to evaluate the exposure of isoflavones including daidzin, glycitin, genistin, daidzein, glycitein, and genistein in rats fed with Semen Sojae Praeparatum (SSP) extract. Plasma samples were pretreated by liquid-liquid extraction with ethyl acetate using quercetin as the internal standard (IS). The chromatographic separation was achieved on a Symmetry C18 column (100 mm × 3.0 mm) using a gradient mobile phase consisting of acetonitril and water (containing 0.1% formic acid) with a run time of 13.0 min at a flow rate of 0.4ml/min. The detection was carried out by a triple-quadrupole tandem mass spectrometer in multiple reaction monitoring (MRM) mode via polarity switching between negative (for and positive (for daidzin glycitin) ionization mode. All calibration curves exhibited good linearity (r> 0.99) over a wide concentration range for all components. The lower limit of quantitation (LLOQ) was in the range of 0.1-0.4 ng/ml. The intra-day and inter-day precisions (RSD) at three different levels were both less than 14.9% and the accuracies (RE) ranged from -9.3% to 14.5%. The extraction recoveries of the analytes and the IS ranged from 85.7% to 100.2%. The validated method was first successfully applied to pharmacokinetic study of the six isoflavones in rat plasma after oral administration of SSP extract. The dynamic baseline levels of six isoflavones in blank plasma from rats consuming food containing dietary isoflavones were measured for the correction of the plasma concentrations. The principle pharmacokinetic parameters were calculated from rats with or without regular commercial food, and found to be altered by the dietary food containing some isoflavones.

Quantification of isoflavone glycosides and aglycones in rat plasma by LC-MS/MS: Troubleshooting of interference from food and its application to pharmacokinetic study of Semen Sojae Praeparatum extract.

In this study, a solid-phase extraction with liquid chromatography and tandem mass spectrometry method was developed to determine the degree of glycosylation of glycosylation sites and the ratio of free carrier protein to total carrier protein for glycoconjugate vaccines. To remove and enrich the glycosylated peptides, a solid-phase extraction method was developed, optimized, and hyphenated to liquid chromatography-tandem mass spectrometry. The developed solid-phase extraction with liquid chromatography-tandem mass spectrometry method was shown to possess a wide linear dynamic range (0.03-100 μg/mL), a high sensitivity (0.03 μg/mL for CRM197), good interday and intra-day precision (relative standard deviation of peak area < 3.3%), and good recoveries from vaccine matrix (90-105%). Finally, the method was utilized to determine the degree of glycosylation and free carrier protein to total carrier protein ratio for pneumococcal conjugate vaccines and meningococcal vaccines. For quality evaluation of glycoconjugate vaccines, the method could provide more information than the traditional size exclusion chromatography method. Fourteen and twelve reported glycosylation sites for CRM197- and tetanus toxin-based vaccines can be detected, respectively.

Determination of glycosylation degree for glycoconjugate vaccines using a solid-phase extraction combined with liquid chromatography and tandem mass spectrometry method.

Zhi-Zi-Chi decoction (ZZCD), comprising of Gardenia jasminoides Ellis (GJE) and Semen sojae preparatum (SSP), is a classical Chinese medicine formula. A novel analysis strategy was set up to obtain an evaluation of ZZCD on attenuation and synergy of compatibility. High-resolution ion trap/time-of-flight mass spectrometry (LC-IT-TOF-MS) was used for qualitative analysis. Variant ingredients were analyzed to compare the componential differences between ZZCD formula and single herbs. Based on our previous fingerprint studies that combined with chemometric methods, 13 remarkable chemical markers were selected and evaluated for quantitative determination by high performance liquid chromatography (HPLC) in three different ratios of ZZCD. 62 compounds in ZZCD, 55 compounds in GJE and 16 compounds in SSP were characterized. The compatibility of GJE and SSP may lead to the undetection of hepatotoxic components such as genipin and the emergence of protective components such as jasminoside A, which was not found in single herbs. Meanwhile, 13 selected chemical markers were successfully determined in three ratios of ZZCD. The compatibility may lead to the decrease of toxic ingredients and the increase of beneficial ingredients. By comparing the dissolution of chemical markers, iridoids in GJE and flavonoids in SSP had the best dissolution when the compatibility ratio was 1:1. This strategy would be a valuable reference for further study on the compatibility of traditional Chinese medicine formula.

Characterization and quantification of the Chinese medical formula Zhi-Zi-Chi decoction, a systematic strategy for the attenuation and synergy of compatibility mechanism.

Article	Year
A new strategy for statistical analysis-based fingerprint establishment: Application to quality assessment of Semen sojae praeparatum. Food chemistry\| PubMed ID: 29655722	2018
Quantification of isoflavone glycosides and aglycones in rat plasma by LC-MS/MS: Troubleshooting of interference from food and its application to pharmacokinetic study of Semen Sojae Praepar... Journal of pharmaceutical and biomedical analysis\| PubMed ID: 30216793	2018
Determination of glycosylation degree for glycoconjugate vaccines using a solid-phase extraction combined with liquid chromatography and tandem mass spectrometry method. Journal of separation science\| PubMed ID: 32388927	2020
Characterization and quantification of the Chinese medical formula Zhi-Zi-Chi decoction, a systematic strategy for the attenuation and synergy of compatibility mechanism. Journal of pharmaceutical and biomedical analysis\| PubMed ID: 36335849	2023

Hongyuan Hao

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