Development of a high-throughput UHPLC–MS-based content uniformity method as a tool for assessing dry powder inhalers

Abstract

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.

Keywords:

• Content uniformity
• dry powder inhaler
• inhalation
• mass spectrometry
• quality-by-design