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Updated: Jun 16, 2026

High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry
Published on: April 23, 2019
Development of a high-throughput UHPLC-MS-based content uniformity method as a tool for assessing dry powder inhalers
Joseph Medendorp1, Brent Donovan, Justin Pennington
1Schering-Plough Research Institute, Oral and Specialty Product Development, Summit, NJ 07901, USA.
Background:
Dry powder inhaler (DPI) product manufacturing requires the assessment of uniformity at various stages of the manufacturing process.
Results:
To efficiently and precisely determine the uniformity of the small doses inherent to DPI technology, an ultrahigh-performance liquid chromatography-mass spectrometry (UHPLC-MS)-based content uniformity method was developed. Using mathematical modeling and proper selection of bracketing standards, a volumetric approximation of sample weight was utilized, eliminating the need for accurate sample weights and reducing sample preparation time.
Conclusion:
UHPLC-MS coupled with mathematical modeling makes high-throughput CU testing of DPI drug products possible which allows for an enhanced understanding of the manufacturing process.
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