APPLICABILITY OF COMPREHENSIVE MOBILE PHASE IN VALIDATED BIO ANALYTICAL QUANTITATIVE ESTIMATION OF ROSUVASTATIN, EZETIMIBE, AMLODIPINE, VALSARTAN, LERCANIDIPINE AND FLUVASTATIN IN HUMAN PLASMA BY RP-HPLC METHOD

Abstract

A bio analytical method was developed with compatible mobile phase for estimation of drugs viz. rosuvastatin and ezetimibe, amlodipine and valsartan, lercanidipine and fluvastatin in human plasma. Liquid chromatographic system takes ample of time to stabilise and to attain equilibrium on changeover of mobile phase. Compatible mobile phase was beneficial to separate and estimate many drugs simultaneously; and saved time and solvent consumption. The technique was developed and equipped with reverse phase high performance liquid chromatograph (RP-HPLC), using RP - C18 column with UV detector. For estimation of all these drugs, the mobile phase [acetonitrile: acetate buffer pH 4.0 (pH adjusted with acetic acid)] was pumped at a flow rate of 0.8 mL min-1 in the ratio of 60:40 V/V and the eluents were monitored at 245 nm. The method was studied and validated as per ICH guidelines and US FDA guidelines for selectivity, specificity, accuracy and precision and stability study. All these drugs shown linear response between concentration and response as a peak area and chromatograms with well resolved peaks were sign of methods efficiency. Statistical data of calibration graph to study linearity of these drugs in biological matrix was found within prescribed limit. Prepared quality control samples were estimated, accuracy and precision results of rosuvastatin and ezetimibe were 97-100.93 as % nominal concentration and 0.8210-2.0367 as % CV for amlodipine and valsartan 98.43-99.81 as % nominal conc. and 0.9480-2.4753 as % CV and for lercanidipine and fluvastatin 97.18-103.5 as % nominal conc and 0.5258-3.8301 as % CV and were within prescribed limit. The bio analytical method is simple as it is free from solvent extraction and solid phase extraction, precise, accurate, and consumes less solvent due to compatible mobile phase. The method suits for quantification of these drugs in plasma, hence applied for bio equivalence, bioavailability study in real clinical samples.