Abstract
A simple, rapid, and reproducible analytical procedure has been developed for the assay of risedronate in pharmaceutical dosage forms. The method is based on ion-pair liquid chromatography with UV detection. Separation is performed on an Eclipse XDB C18 (4.6 x 150mm2, 3.5 μm particles) column, using 5 mM tetrabutylammonium phosphate as counter-ion in the mobile phase. The proposed method was extensively validated according to ICH guidelines for the assay determination. A linear relationship was found in the concentration range studied from 50 to 150 μg risedronate sodium per 25 μL injection. The method precision was below 1.2% relative standard deviation (RSD) (n = 9). The mean recovery of risedronate from commercial tablets was found to be in the range of 99.3-100.6%. The limit of detection (LOD) and limit of quantification (LOQ) of risedronate were found to be 30 and 100 ng, respectively. Since the method is stability indicating, it is also well suited for shelf-life studies of risedronate pharmaceutical preparations.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 2799-2813 |
| Number of pages | 15 |
| Journal | Journal of Liquid Chromatography and Related Technologies |
| Volume | 27 |
| Issue number | 17 |
| DOIs | |
| State | Published - 2004 |
| Externally published | Yes |
All Science Journal Classification (ASJC) codes
- Analytical Chemistry
- Biochemistry
- Pharmaceutical Science
- Clinical Biochemistry
Keywords
- Actonel tablets
- Assay
- Eclipse XDB C
- Ion-pair HPLC
- Risedronate
- Stability indicating
- UV detection
- Validation