ANALYTICAL METHOD VALIDATION FOR DETERMINATION OF HEAVY METAL IN CAPSULE SHELL BY USING INDUCTIVELY COUPLED PLASMA MASS SPECTROMETRY (ICP-MS).

A precise, linear, accurate, sensitive and selective eco friendly analytical method has been developed and validated using inductively coupled plasma mass spectrometry (ICP-MS) for the determination of heavy metal Arsenic (As), Mercury (Hg), Lead (Pb) and Cadmium (Cd) in hard gelatin capsule shell. Arsenic, Mercury, Lead and Cadmium are heavy metal and heavy metals are a genotoxic in nature. These heavy metals follows under class I category therefore ICH guidelines Q3D have control limit base on its risk assessment. The developed analytical method was selective and sensitive for capable detecting heavy metal as 0.006ppm As, 0.002ppm Hg, 0.019ppm Pb, 0.005ppm Cd and further quantified from 0.020ppm As, 0.012ppm Hg, 0.063ppm Pb, 0.017ppm Cd to 200 percent of limit concentration. The analytical method found to be linear with working concentration range from 0.986 ppb to 100 ppb for As, 0.856ppb to 50 ppb Cd, 0.302 ppb to 10 ppb Hg and 3.127 ppb to 100 ppb Pb with correlation coefficient 1.0000 As, 1.000 Cd, 0.9999 Hg and 0.9998 Pb. The percentage recoveries of heavy metals at three different concentrations with spiking in samples of hard gelatin capsule were found to be an acceptable range as 70% to 130 %. The method was precise and robust and its relative standard deviation was below 25%. The actual % RSD in precision are 5.67% As, 5.19% Cd, 3.79% Hg and 5.34% Pb. Therefore the developed method can use for routinely quantitative determination of heavy metal in hard gelatin capsule shell to ensure the quality of capsule shell.