Muhammad Abdul Qadir, Mahmood Ahmed, Iftikharul Haq, Saghir Ahmed.
Improved limit of detection and quantitation development and validation procedure for quantification of zinc in Insulin by atomic absorption spectrometry..
Pak J Pharm Sci Jan ;28(3):875-9.

A simple and expeditious analytical method for determination of zinc in human insulin isophane suspension by flame atomic absorption spectrophotometer (FAAS) was validated. The method was carried out on atomic absorption spectrometer with 0.4 nm bandwidth, 1.0 filter factor on deuterium (D2) background correction. The integration time was set at 3.0 second with 5.0 mA lamp current. The parameters of method validation showed adequate linearity, efficiency and relative standard deviation values were between 0.64%-1.69% (n=7), 1.31%-1.58% (n=10) for repeatability and intermediate precision respectively. The limit of detection 0.0032 mug/mL, 0.0173 mug/mL, 0.0231 mug/mL and limit of quantitation 0.0107mug/mL, 0.0578 mug/mL, 0.0694 mug/mL based on signal to noise (SN), calibration curve method (CCM) and fortification of blank (FB) were obtained respectively. The percentages of recovery for low, medium and high spiked concentration levels of zinc in human insulin were 99.38 +/- 0.04 to 100.3 +/- 0.03, 98.45 +/- 0.38 to 100.3 +/- 0.07 and 99.42 +/- 0.03 to 99.42 +/- 0.08 respectively. With the use of this method, five samples from each vial of human insulin isophane suspension were analyzed and the zinc content was determined. The zinc content were 22.1 +/- 0.025 mug/mL and 24.3 +/- 0.028 mug/mL which compliance the British Pharmacopoeia standard.

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