Vol. 12, Issue 2 (2023)

Author(s):
Pulagurtha Bhaskararao, Kontham Venkataramanapa Raju and Balla Sujiya

Abstract:
The present study is aimed at developing and validating an accurate, precise, linear and robust micellar liquid chromatographic method for the simultaneous estimation of amlodipine besylate (AB) and atorvastatin calcium (AC) in pharmaceutical dosage forms. The analysis of AB and AC is done with a mixture of n-butanol and polysorbate 20 (0.05 M) in the ratio of 30:70 (v/v) as mobile phase and Phenomenex C18 column (150 mm × 4.6 mm, 5 µm) as stationary phase. The chromatographic peaks of AB and AC were detected and measured at 240 nm. The retention times of AB and AC were found to be 3.61 min and 6.53 min, respectively. The developed method is demonstrated to access its suitability for meeting its intended purpose by the validation with a set of validation parameters as per ICH and USP guidelines. The method is proved to be linear from 5 to 50 µg/ml for AB and 10 to 100 µg/ml for AC with the correlation coefficients of 0.9995 and 0.9990, respectively. The method is found to be precise with percent relative standard deviation value in range 0.8-1.1% and 0.5-1.0% and accurate with recoveries of 99.20 to 101.20% and 98.80 to 100.67% for AB and AC respectively.