Method Development and Validation of Antihypertensive Drugs Using HPLC Technique

Aim

A validated RP-HPLC method was established for the quantification of Amlodipine and Metoprolol succinate according to ICH guidelines.

Materials and Methods

This method utilized a Phenomenex (US) C₁₈ column with dimensions of 250X4.6 mm I.D and a particle size of 5 µm. Employing an isocratic elution technique, the mobile phase comprised pH 3.0 phosphate buffer solution and acetonitrile. Detection occurred at a wavelength of 215 nm and a flow rate of 1 mL/min was chosen to ensure optimal resolution for Amlodipine and Metoprolol succinate.

Results and Discussion

Retention times were noted at 3.137 min and 5.672 min for Amlodipine and Metoprolol succinate, respectively. High correlation coefficients were achieved (0.9995 for Amlodipine and 0.9996 for Metoprolol succinate). The method exhibited precision, with low relative standard deviations of 0.357% for Amlodipine and 0.077% for Metoprolol succinate. In summary, the RP-HPLC method developed was specific, linear, precise and robust.

Conclusion

The devised method was validated in terms of accuracy, precision, linearity, specificity, robustness and ruggedness. All formulations’ sample recoveries were in good accordance with the claims made on their labels