VALIDATION OF STABILITY INDICATING ULTRA-FAST LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS ESTIMATION OF ATENOLOL and NIFEDIPINE IN BOTH BULK AND PHARMACEUTICAL DOSAGE FORMS
Keywords:Atenolol, ICH guidelines, Nifedipine, Stability indicating studies, UFLC
Objective: The study depicts improvement of ensuing validation of a stability indicating technique for the simultaneous estimation of Atenolol and Nifedipine using Ultra-fast liquid chromatographic method (UFLC).
Methods: The analysis is performed on Phenomenex Kinetex C18, (150 Ã— 4.6 mm, 5Î¼m) column using methanol and 0.1%ortho-phosphoric acids (75:25 v/v) as mobile phase with a flow rate of 1.3 ml/min. The eluents were checked with PDA detector at 237 nm.
Results: In this optimized conditions Atenolol and Nifedipine elutes at a retention time of 2.79 and 4.50 min respectively individually the considered optimized condition is having linearity in the range from 10 to 50Âµg/ml of Atenolol and 4-20Âµg/ml of Nifedipine. The method was validated by following the ICH guidelines and their combination drug yield was exposed to acid and base stress, thermal stress, photolytic stress, hydrolytic stress, and oxidative stress conditions. All samples were studied by the given optimized method. In this Calibration curves were linear over studies ranges with correlation coefficient found between the ranges of 0.99 to 1.00.
Conclusion: The proposed method was found to be accurate, precise, and specific and suitable for determination of both the drugs.
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