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- Title
Reverse-phase high-performance liquid chromatographic method development and validation for the simultaneous estimation of Hydrochlorothiazide and Propranolol in bulk and Pharmaceutical dosage form in biorelevant dissolution media.
- Authors
Shanmugasundaram, Palani; Kamarapu, S. K.
- Abstract
Objective: A simple, rapid, and precise reverse-phase high-performance liquid chromatographic (RP-HPLC) method for simultaneous analysis of Hydrochlorothiazide and Propranolol in a bulk and tablet dosage form in biorelevant dissolution medium has been developed and validated. Methods: The chromatographic separation was achieved using reverse phase C18 column; Symmetry C18 column (250 mm × 4.6 mm × 5µm). The mobile phase used was a mixture of acetonitrile:potassium dihydrogen phosphate solution (0.01 M, pH 3.0 adjusting with Orthophosphoric acid) in a ratio of 60:40 at isocratic mode and eluents were monitored at 275 nm using PDA detector. Results: By the method, Hydrochlorothiazide and Propranolol were eluted with retention times of 2.033 min and 3.280 min, respectively. The method was continued and validated accordance with ICH guidelines. Validation revealed the method is rapid, specific, accurate, precise, reliable, and reproducible. Calibration curve plots were linear over the concentration ranges 20-60 µg/mL for Hydrochlorothiazide and 20-60 µg/mL for Propranolol. Limits of detection was 0.73 and 0.95 µg/ml and limits of quantification was 2.19 and 3.01 µg/mL for Hydrochlorothiazide and Propranolol, respectively. Conclusion: The statistical analysis was proves the method is suitable for the analysis of Hydrochlorothiazide and Propranolol as a bulk and tablet dosage form in biorelevant dissolution media (Fasted State Simulated Intestinal Fluid-FaSSIF) without any interference from the excipients.
- Subjects
HIGH performance liquid chromatography; DRUG solubility; HYDROCHLOROTHIAZIDE; PROPRANOLOL; DOSAGE forms of drugs
- Publication
Drug Invention Today, 2018, Vol 10, Issue 2, p202
- ISSN
0975-7619
- Publication type
Article