Quantitative analysis of finasteride tablets dissolution content with non-isotopically labeled internal standard by paper spray ionization mass spectrometry.

Abstract

Paper spray ionization, one of the ambient mass spectrometry technologies, has been developed to characterize the content of drugs in various complex matrixes including urine, whole blood, dissolution solutions, and so on. An isotopically labeled compound as internal standard is often used in quantitative paper spray ionization experiments. But high cost and difficult to access impede the application of this type of internal standards. Application of non-isotopically labeled compounds as internal standards will make this technology more prevalent. In this paper, we explored the application of finasteride impurity as the internal standard in paper spray ionization-mass spectrometry to measure the dissolution content of finasteride tablets. The new method was optimized and the results were compared to those from high-performance liquid chromatography. The whole analysis time was several minutes and limit of detection for finasteride was around 4.8ng/mL. The results from paper spray ionization-mass spectrometry were similar to those from high-performance liquid chromatography. Combination of paper spray ionization-mass spectrometry and non-isotopically labeled internal standard renders a new method to analyze drug dissolution content with high specificity, low limit of detection, and simple sample preparation within short time period.