This study investigated the comparison of USP-L10 and USP-L7 columns for dissolution and assay testing of norethindrone/mestranol tablets. The results showed that the USP-L10 column provided better peak separation for dissolution testing, while the USP-L7 column provided higher recovery for assay testing.
This document presents an HPLC application for the separation of norethindrone and mestranol, utilizing progesterone as an internal standard. The study compares the performance of the Eclipse XDB-CN (L10) and Eclipse XDB-C8 (L7) columns against USP Formulary requirements for dissolution and assay testing of norethindrone/mestranol tablets.
The results indicate that both columns meet or exceed the specified performance measures, including theoretical plates, tailing factors, and resolution. The Eclipse XDB-CN column is highlighted for providing faster analysis times and lower costs while maintaining high-resolution separations suitable for both dissolution and assay methods.
| Column Dimensions | 4.6 mm x 150 mm |
|---|---|
| Particle Size | 5 pm |
| Flow Rate | 1 mL/min |
| Temperature | 25 °C |
| Detection Wavelength | 205 nm |
| Injection Volume | 5 microliter |
Progesterone is used as the internal standard (ISTD) for the assay method.
Yes, the Eclipse XDB-CN column easily meets the requirements for the dissolution method.