Hydrophilic interaction chromatography with aerosol-based detectors (ELSD, CAD, NQAD) for polar compounds lacking a UV chromophore in an intravenous formulation

Aerosol-based detectors for liquid chromatography

“…As described earlier, Cintrón and Risley measured nonchromophoric drug substances in a mannitol intravenous formulation using HILIC with three different aerosol-based detectors (ELSD, CAD and NQAD) [83]. All three detector-types provided satisfactory results for mannitol and the test drug, although CAD and NQAD had the lowest LODs and required additional sample dilution.…”

“…Cintrón and Risley [83] evaluated a HILIC method, otherwise primarily developed for use with ELSD for determination of a pharmaceutical substance in a mannitol IV formulation, for linearity and detection limit with CNLSD. The detection limit was found to be 1 g/mL for CNLSD (and CAD), which was 10-50x lower than obtained with ELSD.…”

“…Cintrón and Risley [83] developed a hydrophilic interaction chromatographic method for polar compounds lacking a UV chromophore in an intravenous formulation and used ELSD, CAD and NQAD for detection. All three detectors exhibited high linearity over relatively short concentration ranges.…”

Recent applications of hydrophilic interaction liquid chromatography in pharmaceutical analysis

“…Following that, according to the difference kind of the detected targets, HILIC applied for chemical drug analysis in formulation and related matrices is summarized. Determination of APIs in complicated formulation is important for the QC of chemical drug in pharmaceutical industry, and various related researches have been proposed through HILIC coupled detection system [83][84][85][86]. In powder for intravenous injection, ␤-lactam antibiotics imipenem, and another active compound cilastatin sodium were determined simultaneously in the presence of degradation product thienamycin [83].…”

A Novel Approach for Quantitation of Nonderivatized Sialic Acid in Protein Therapeutics Using Hydrophilic Interaction Chromatographic Separation and Nano Quantity Analyte Detection

“…Data transformation must be applied to the ELSD data response to generate a linear function. With data tranformation, ELSDs such as Alltech 800 ELSD and ELSD 3300 have demonstrated excellent linearity in addition to the acceptable accuracy, precision (repeatability and intra‐assay precisions), specificity, robustness, and stability . However, NQAD detector has been demonstrated to be 50‐ and 10‐fold more sensitive than ELSD 800 and ELSD 3300 with LODs of 50,10, and 1 g/mL for ELSD 800, ELSD 3300, and NQAD, respectively.…”