ESTIMATION OF HEAVY METALS IN DIFFERENT BRANDS OF AMLODIPINE BESYLATE TABLET DOSAGE FORMS BY INDUCTIVELY COUPLED PLASMA-MASS SPECTROMETRY (ICP-MS)

Abstract

The aim of this study is to estimate heavy metals in different brands of amlodipine besylate tablet dosage forms by inductively coupled plasma-mass spectrometry (ICP-MS). In many laboratories around the world as the instrument of choice for performing trace metal analysis is ICP-MS. ICP-MS using Kinetic Energy Discrimination (KED) mode was used. Samples are assimilated using multi-wave sample digestion system. Each element standards of conc. 1000 mg/l was prepared and followed by serial dilution with 2% nitric acid. The validation was performed as per USP232 standards for the different brands of commercially available samples. Parameters such as linearity, accuracy, precision, Limit of detection (LOD), Limit of Quantification (LOQ) were evaluated. Calibration curves were linear and co-relation co-efficient (r2) was 0.995 for all elements. LOD is divided into two components, method detection limit (MDL) and instrumental detection limit (IDL). The MDL limits (in ppb) of 75As, 111Cd, 208Pb, 202Hg, 52Cr, 60Ni were found to be 8.55, 0.15, 1.35, 1.5, 1.95 and 5.4 respectively. The IDL limits (in ppb) of 75As, 111Cd, 208Pb, 202Hg, 52Cr, 60Ni were found to be 0.005, 0.003, 0.003, 0.003, 0.0018, and 0.0021 respectively. In three different brands of amlodipine besylate tablets, elements like 75As, 111Cd, 208Pb, 202Hg, 52Cr, 60Ni were estimated by a validated method of ICP-MS. The obtained results show us that this method could be used in the laboratory for the estimation of trace elements in amlodipine besylate in tablet dosage form using ICP-MS.