Abstract
A simple, accurate, precise and robust reverse phase high performance liquid chromatographic method has been developed and subsequently validated for the simultaneous estimation of atorvastatin (AT), ezetimibe (EZ) and fenofibrate (FE) in commercial formulation. The method has shown an adequate separation for AT, EZ and FE. The drugs were resolved on an enable C-18 Column (25 mm x 4.6 mm i.d, 5 μm particle size) using Shimadzu SPD-20A prominence UV-Visible detector with the mobile phase composed of acetonitrile and phosphate buffer (pH 3.3) in the ratio of 90:10% V/V as mobile phase at a flow rate of 1 mL/min and the detection was carried out at 254 nm. The retention time of AT, EZ and FE were found to be 3.155, 5.299 and 6.215 min respectively. The linearity of the proposed method was investigated in the range of 10-100 μg/mL, 10-100 μg/mL, and 160-1600 μg/mL for AT, EZ and FE, respectively. The limit of detection (LOD) was 2.18, 0.87, and 20.9 for AT, EZ and FE, respectively. The limit of quantification (LOQ) was 6.8, 2.6 and 63.6 for AT, EZ and FE, respectively. The % RSD from the precision and accuracy studies was found to be below 2%. The proposed method was statistically evaluated and can be applied in regular quality control of AT, EZ and FE in pharmaceutical dosage forms.
Highlights
Lowering low-density lipoprotein cholesterol (LDL-C) with the use of the most potent statins improves mortality and morbidity related to cardiovascular events in patients with hypercholesterolemia
Treatment with FE monotherapy has been proven to provide modest reductions in LDL-C, and may be an effective therapeutic option for patients who are intolerant of statins [5]
In contrast to monotherapy where both EZ and FE each provide only modest effect, the combined therapy produces significantly greater reductions in LDL-C. This combination of EZ and FE in most of the cases is effective as AT and may be an effective second-line therapeutic option in patients who are intolerant to statins, but still require medication for elevated cholesterol
Summary
Lowering low-density lipoprotein cholesterol (LDL-C) with the use of the most potent statins improves mortality and morbidity related to cardiovascular events in patients with hypercholesterolemia. In contrast to monotherapy where both EZ and FE each provide only modest effect, the combined therapy produces significantly greater reductions in LDL-C This combination of EZ and FE in most of the cases is effective as AT and may be an effective second-line therapeutic option in patients who are intolerant to statins, but still require medication for elevated cholesterol. Pathak et al, reported RP-HPLC and chemometric assisted UVspectrophotometric methods for simultaneous analysis of the three drugs in combined dosage form [13]. A gradient HPLC and a HPTLC method have been demonstrated by Varghese et al, for quantitative simultaneous determination of the said drugs. Instrumentation The liquid chromatographic system was a Binary Shimadzu prominence HPLC System in gradient mode with a 20 μL sample injection loop (manual) and SPD 20A Photo diode array UV-Visible detector. An Analytical balance (Shimadzu uniblock ATX 124, 0.1 mg sensitivity), a sonicator (SONICA, Spincotech Pvt Ltd.) were used in this study
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