Simultaneous Resolution and Detection of a Drug Substance, Impurities, and Counter Ion Using A Mixed-Mode HPLC Column with Evaporative Light Scattering Detection

Lantz, Michael D.; Risley, Donald S.; Peterson, Jeffery A.

doi:10.1080/10826079708010984

Cited by 25 publications

(6 citation statements)

References 26 publications

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“…ELSD has been reported for the quantitation of mannitol in urine with detection limits of 0.65 mg/L [9]. Other applications using ELSD have been reported including inorganic salts [35,37] and active pharmaceutical compounds [31 -34]. In fact, many of the inactive ingredients used to formulate pharmaceuticals are capable of being detected by ELSD making it essentially a universal detector for the diverse types of analytes in pharmaceutical formulations.…”

Section: Resultsmentioning

confidence: 99%

Analysis of mannitol in pharmaceutical formulations using hydrophilic interaction liquid chromatography with evaporative light-scattering detection

Risley¹,

Yang

Peterson

2006

J. Sep. Science

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This study demonstrates the use of hydrophilic interaction liquid chromatography (HILIC) for the separation of both active and inactive ingredients in pharmaceuticals from a single injection. Excipients commonly used in parenteral formulations were separated using a gradient method employing increasing aqueous composition. An evaporative light-scattering detector (ELSD) provided direct detection of inactive excipients and inorganic salts lacking UV chromophores. Analyses of Gemzar parenteral formulations using optimized isocratic HILIC-ELSD method conditions were performed based on retention time screening from the gradient assay. All of the components were efficiently separated using a TSK-Gel Amide 80 column including gemcitabine, mannitol, and sodium cation demonstrating the qualitative capability of the technique. The method was thoroughly validated for mannitol content to access the quantitative potential of the technique. Validation parameters included linearity, accuracy, specificity, solution stability, repeatability, and intermediate precision. Overall, the method described in this report proved to be very robust and represents a novel technique to conveniently separate and detect the active and inactive components in pharmaceuticals both quickly and accurately.

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Section: Resultsmentioning

confidence: 99%

Analysis of mannitol in pharmaceutical formulations using hydrophilic interaction liquid chromatography with evaporative light-scattering detection

Risley¹,

Yang

Peterson

2006

J. Sep. Science

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“…Fluorescence detectors [61][62][63], spectrophotometric detectors [64], light scattering detectors [65,66], and electrochemical detectors [57,[67][68][69] are also used. It exhibits high sensitivity, stability, and reliability and allows the operation in the gradient elution mode.…”

Section: Determination Of Organic Impurities In Pharmaceutical Preparmentioning

confidence: 99%

Determination of organic impurities in pharmaceutical preparations

2005

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“…It exhibits high sensitivity, stability, and reliability and allows the operation in the gradient elution mode. Fluorescence detectors [61][62][63], spectrophotometric detectors [64], light scattering detectors [65,66], and electrochemical detectors [57,[67][68][69] are also used.…”

Section: Determination Of Organic Impurities In Pharmaceutical Preparmentioning

confidence: 99%

Determination of organic impurities in pharmaceutical preparations

Glazkov

Bochkareva²,

Revel'skii

2005

J Anal Chem

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Simultaneous Resolution and Detection of a Drug Substance, Impurities, and Counter Ion Using A Mixed-Mode HPLC Column with Evaporative Light Scattering Detection

Cited by 25 publications

References 26 publications

Analysis of mannitol in pharmaceutical formulations using hydrophilic interaction liquid chromatography with evaporative light-scattering detection

Analysis of mannitol in pharmaceutical formulations using hydrophilic interaction liquid chromatography with evaporative light-scattering detection

Determination of organic impurities in pharmaceutical preparations

Determination of organic impurities in pharmaceutical preparations

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