HPLC–MS–MS for the Simultaneous Determination of Atorvastatin and Amlodipine in Plasma of Hypertensive Patients

Abstract

Combination drug products containing amlodipine and atorvastatin are widely marketed and used in the treatment of concomitant hypertension and dyslipidemia. A rapid, simple and sensitive high performance liquid chromatography-tandem mass spectrometry (HPLC-MS-MS) method for determination of atorvastatin and amlodipine in plasma of hypertensive patients has been developed and validated to be used for therapeutic drug monitoring. The plasma samples were subjected to methanol protein precipitation. Chromatographic separation was performed on a C18 column using a gradient elution. The mobile phase consisted of 0.1% of formic acid in water and 0.1% of formic acid in acetonitrile and was pumped at a flow rate of 0.4 mL min -1 . Detection of analytes was achieved by tandem mass spectrometry with electrospray ionization (ESI) interface in positive ion mode. The calibration curves were linear over the range of 0.46-1,000 ng mL -1 . The intra-and inter-day precisions were within 12.2%, while the accuracy ranged from 92.7 to 108.1%. The validated LC-MS-MS method was successfully applied for the determination of atorvastatin and amlodipine in plasma of hypertensive patients.

A Review of Current Trends and Advances in Analytical Methods for Determination of Statins: Chromatography and Capillary Electrophoresis

“…Therefore, these methods could be useful in daily routine sample handling, when many samples from patients taking different drugs together with HMG-CoA reductase inhibitors are analyzed in clinical laboratories. Recently, several chromatographic methods have been developed for the quantification of statin drugs in combination with other drugs, most of them are commonly used in treatment of cardiovascular disease: atenolol, spironolactone, glibenclamide [61], metoprolol succinate [72], valsartan and chlorthalidone [76,87], timolol maleate, diclofenac sodium [81], fenofibric acid [85], ezetimibe [91], ceftriaxone [92], acetylsalicylic acid [94], amlodipine [98] and losartan, atenolol, acetylsalicylic acid [99].…”

Chemometric resolution of coeluting peaks of eleven antihypertensives from multiple classes in high performance liquid chromatography: A comprehensive research in human serum, health product and Chinese patent medicine samples

“…In principle, the joint of complementary medicines can not only help to meet the target blood pressure, but also decrease the morbidity and mortality of complications. In practice, many doctors as well as the World Health Organization have been beginning to detector (UV) [10][11][12][13], fluorescence detector (FD) [14,15], amperometric detector (AD) [16], diode array detector (DAD) [17][18][19] and mass spectrometry (MS) [20][21][22]. However, most works have been focused on quantifying a small amount or one kind of antihypertensives in biological matrix or Chinese herbal matrix.…”

Development of a Stability-Indicating HPLC Method for Simultaneous Determination of Amlodipine Besylate and Atorvastatin Calcium in Bulk and Pharmaceutical Dosage Form

“…Coupled with Fluorescence Detection [12] Capillary Electrophoresis [3] HPLC Coupled with UV Detection [13][14][15][16][17], HPLC-MS-MS [18][19][20], RP-UPLC [21,22]. Stability testing and stress testing (forced degradation studies) are critical components of drug development strategy.…”