Stability‐indicating HPLC‐DAD Method for Simultaneous Determination of Atorvastatin, Irbesartan, and Amlodipine in Bulk and Pharmaceutical Preparations

Abstract

The present study describes a convenient stability-indicating HPLC-DAD method for the separation and simultaneous determination of the drugs atorvastatin, irbesartan, and amlodipine in bulk and formulations. The method proposed demonstrated good separation between atorvastatin, irbesartan, amlodipine and their main degradation products. Separation was executed on a Waters XBrigde C18 column (5 μm, 25 × 0.46 cm) using a gradient mobile phase system consisting of acetonitrile and orthophosphoric acid buffer (pH 2.2) at a flow rate of 1 mL/min and UV detection at 240 nm. The drugs were subjected to acidic and basic hydrolysis, oxidation, exposure to UV light, and exposure to temperature (dry heat) to apply stress conditions. Linearity of the method was evaluated in the range 5-30 μg/mL for each drug with correlation coefficient values (r 2 ) of 0.9982, 0.9973, and 0.9986 for atorvastatin, irbesartan, and amlodipine, respectively. The limits of detection were 0.05, 0.06, and 0.08 μg/mL for the three compounds, respectively. No interference was observed with the detection of the compounds in presence of degradable products; hence, it is confirmed that the analysis is stability-indicating.

DoE-empowered development and validation of an environmentally sustainable RP-HPLC method for simultaneous estimation of antihypertensive drugs: AQbD perspective

“…There isn't yet a working RP-HPLC technique for AM and IRB that was created utilising the AQbD methodology. Since every established approach has used non green solvents [16][17][18] which are toxic to the environment. As a result, the designed and verified RP-HPLC provides a robust, cost effective and a rapid method to estimate AM and IRB in bulk and tablet form with shorter retention times (2.3 and 3.3 min).…”

Response surface design as a powerful tool for the development of environmentally benign HPLC methods for the determination of two antihypertensive combinations: Greenness assessment by two green analytical chemistry evaluation tools

“…During literature survey, many methods were found for the simultaneous analysis of both amlodipine and atorvastatin in their combined dosage form. Those methods include HPLC , LC–MS/MS , and spectrophotometry . Nevertheless, all the reported chromatographic methods utilized organic solvents that are environmentally unfriendly.…”

Synthesis and Spectroscopic Characterization of Metal Complexes of Rosuvastatin

“…5 It is newer drug with 20% bioavail ability 6,7 and 19 hours elimination halflife. 8 Like other statins it principally reduces total cholesterol (in hypercholesterolemia), LDL cholesterol (in hyperlipoproteinemia), triglycerides (in hypertriglyceridemia), lip ids (in dyslipidemia) and increases HDL cholesterol (in hypolipoprteinemia) 9 to cure atherosclerosis, thrombosis 3 and coronary artery disease. 4 Long term statin therapy usually needs coadministration of different classes of drugs 10 and multivitamins that include essential and trace elements.…”

“…4 Long term statin therapy usually needs coadministration of different classes of drugs 10 and multivitamins that include essential and trace elements. 11,9 Most often the combination of drugs inside body may either increase or reduce the efficacy of either drug or themselves; or may cause any side effects; or may be support Submission Date: 16-10-2016; Revision Date: 25-11-2016; Accepted Date: 27-11-2016 ive in any other activity. Itraconazole increases peak plasma concentration of rosuvastatin when taken simultaneously.…”