Simultaneous determination of amlodipine besylate and atorvastatin calcium by using spectrophotometric method with multivariate calibration and HPLC method implementing "design of experiment"
Article
Ibrahim, N, Rizk, M, Ibrahim, A et al. (2014). Simultaneous determination of amlodipine besylate and atorvastatin calcium by using spectrophotometric method with multivariate calibration and HPLC method implementing "design of experiment"
. 6(1), 419-425.
Ibrahim, N, Rizk, M, Ibrahim, A et al. (2014). Simultaneous determination of amlodipine besylate and atorvastatin calcium by using spectrophotometric method with multivariate calibration and HPLC method implementing "design of experiment"
. 6(1), 419-425.
Objectives: The aim of the present work is to develop a rapid and simple method for the simultaneous determination of amlodipine besylate and atorvastatin calcium mixture by two different methods. First, Multivariate calibration methods using preprocessing to enhance results in case of presence of any interference in samples. Second, RP-HPLC method for achieving a good separation of the mixture with accepted system suitability parameters with using design of experiment in the robustness study according to Plackett-Burman design. Methods: The method is based on the spectrophotometric measurements of the drugs in the range of 200-400 nm together with multivariate calibration methods. Resolution of the binary mixture under investigation has been accomplished mainly by using partial least squares (PLS) and principal component regression (PCR). The proposed RP-HPLC method utilizes a YMC-pack pro C18 ODS-A (25 cm x 4.6 mm, 5 μm) column, at room temperature, optimum mobile phase consisted of methanol and 0.01 M sodium dihydrogen phosphate buffer (75:25, v/v), pH adjusted to 3.5 with orthophosphoric acid solution. The flow rate was monitored at 1.2 ml/min, and UV detection at 239 nm. Results: The recovery percentage for amlodipine besylate and atorvastatin calcium in tablets dosage form were found to be in PLS method (98.98 ± 0.85, 99.68 ± 1.35), PCR method (99.16 ± 0.75, 99.60 ± 1.40) and RP-HPLC method (98.82 ± 0.62, 101.19 ± 0.69), respectively. Conclusion: The methods were validated as per ICH guidelines. All the results obtained were found to be within the acceptable limits. The methods were successful to estimate amlodipine besylate and atorvastatin calcium in bulk powder and pharmaceutical preparation Caduet®.
