Method Development and Validation for Simultaneous Determination of Amlodipine Besylate and Atorvastatin Calcium by RP-HPLC Technique

摘要

The present study describes a simple, accurate and precise RP-HPLC technique for the simultaneous determination of Amlodipine Besylate and Atorvastatin Calcium in pharmaceutical dosage form. The method involves an isocratic elution of drug in a stationary phase of Waters X-Terra, C_(18) (150mm × 4.6mm, Sum) column using a mobile phase composition of methanol and 10mM sodium acetate buffered to pH 4 in the composition ratio of 70:30 v/v with a flow rate of 1.0 mL/min at 240 nm of detection. The injection volume is 20 μL. the method has been validated for specificity, linearity, range, precision, accuracy, limit of detection, limit of quantification, ruggedness and robustness. The retention times for Amlodipine Besylate and Atorvastatin Calcium are about 2.28 and 7.71 minutes respectively. Quantitative linearity was observed over the concentration range of 2.51 to 50.18 μg/mL for Amlodipine Besylate and 5.02 to 100.33 μg/mL for Atorvastatin Calcium respectively, The regression equations of concentration of Amlodipine Besylate and Atorvastatin Calcium are found to be y = 41001x + 39729, y = 52986x + 12518 respectively where y is the peak area and × is the concentration of drug (μg/mL). The % recovery of Amlodipine Besylate and Atorvastatin Calcium are found to be in the range of 97 % to 100 %. All the validation parameters are within the acceptance range.