Abstract
Objectives: The aim of the present work is to develop rapid and simple methods for the simultaneous determination of atenolol and nifedipine. Multivariate calibration using preprocessing methods to enhance results in case of presence of any interference in samples and RP-HPLC method for achieving a good separation with accepted system suitability parameters with the use of design of experiment for robustness testing according to Plackett-Burman design. Methods: The spectrophotometric method is based on the measurement of the mixture in the range of 200-400 nm then applies the multivariate calibration methods for resolution of the binary mixture mainly using partial least squares (PLS) and principal component regression (PCR). The proposed RP-HPLC method utilizes an YMC-pack pro C18 column (250 mm x 4.6 mm, 5 μm). Optimum chromatographic conditions were attained by application of Design of experiment (DOE). Both spectrophotometric and chromatographic methods were applied on the determination of both drugs in marketed capsules. Also, dissolution testing of these capsules was investigated. Results: The recovery percentage for nifedipine and atenolol in capsules dosage form were found to be in PLS method (100.50 ± 0.850, 100.78 ± 1.07), PCR method (100.60 ± 0.960, 100.72 ± 1.09) and RP-HPLC method (99.77 ± 0.560, 100.90 ± 1.23); respectively. Conclusion: The methods were validated according to ICH guidelines. All the results obtained were found to be within the acceptable limits. The methods were successful to estimate nifedipine and atenolol in bulk powder and pharmaceutical preparation.
Highlights
Nifedipine [3, 5-dimethyl 2, 6-dimethyl-4-(2-nitrophenyl) - 1, 4-dihydropyridine-3, 5-dicarboxylate] [1]
Multivariate calibration In principal component regression (PCR) and partial least squares (PLS) methods, data were mean centered as a preprocessing step and leave one out was applied as a cross validation method [23]
To select the optimum number of PCR factors (PCs) and LVs, F statistics was used in which the root mean square error of cross validation (RMSECV) values were compared and the selected model was that with the smallest number of factors such that RMSECV for that model was not significantly greater than RMSECV from the model with an additional factor (LV) [24]
Summary
Nifedipine [3, 5-dimethyl 2, 6-dimethyl-4-(2-nitrophenyl) - 1, 4-dihydropyridine-3, 5-dicarboxylate] [1]. It is a calcium channel blocker that inhibits the trans membrane influx of calcium ions into vascular smooth muscle and cardiac muscle [2].Atenolol [(RS)-2-[4[2-hydroxy-3-(propan-2-ylamino) propoxy] phenyl] acetamide] [1]. It is a Beta blocker that interferes with the binding to the receptor of epinephrine and other stress hormones, and weakens the effects of these hormones. Beta blockers are used for the management of cardiac arrhythmias, protecting the heart from a second heart attack (myocardial infarction) after a first heart attack (secondary prevention), and hypertension [3]. The combination dosage form of nifedipine and atenolol are available in the market for the treatment of hypertension.
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