The present investigation analyzed a validated stability-indicating RP-HPLC method for Atenolol and Nitrendipine was developed by separating its related impurities. Atenolol is a selective beta 1 blocker that can be used alone or in combination with hydrochlorothiazide or with chlorthalidone for the treatment of hypertension and prevention from a heart attack.
By using Waters HPLC e-2695 quaternary pump with a PDA detector of 2998 instrument, the chromatographic separation of Atenolol, Nitrendipine and its related impurities was achieved on the column of Agilent eclipse C18 (150x4.6 mm, 3.5 µ) using gradient elution with a buffer containing 0.1percent formic acid and acetonitrile as a mobile phase with a flow rate of 1 ml/min at ambient temperature. A detector wavelength of 218 nm utilizing the PDA detector was given in the instrumental settings. Validation of the proposed method was carried out according to an International Conference on Harmonization (ICH) guidelines.
In relation to the test concentration, LOD and LOQ were established for Atenolol and its impurities. The regression coefficient for the plotted calibration curves was R2>0.999, indicating that the linearity was within the limit. The results were found to be within the allowable limit as a result of determining parameters like specificity, linearity, accuracy, ruggedness, and robustness as part of method validation. With a runtime of 40 minutes, high efficiency, and compliance with the USP's modified SST specifications, the developed method produced positive results for Atenolol, Nitrendipine, and their associated impurities. The current work's use of an Agilent eclipse C18 column has produced better analyte elution with good resolution, improved plate count, and reduced tailing.
The developed method was found to be useful for measuring active pharmaceutical ingredients and to be applicable to routine analysis (i. e, Atenolol, Nitrendipine and their related impurities). Since Atenolol, Nitrendipine, and their related impurities have no HPLC method reported in the literature, it is necessary to develop quantitative methods under various circumstances to improve specificity, selectivity, etc.