Research Article
A Validated RP-HPLC Stability Method for the Estimation of Chlorthalidone and Its Process-Related Impurities in an API and Tablet Formulation
Table 7
Robustness values for the chlorthalidone and the in-house process-related impurities.
| Sr. no. | Name | Control | pH | Flow rate | Wavelength | RRT | | pH 5.3 | pH 5.7 | 1.2 mL/min | 1.6 mL/min | 218 nm | 222 nm |
| 1 | Chlorthalidone | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 2 | Stage II process impurity | 4.91 | 4.98 | 4.89 | 4.90 | 4.93 | 4.92 | 4.91 | 3 | Stage III process impurity | 1.45 | 1.49 | 1.42 | 1.45 | 1.44 | 1.46 | 1.45 |
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