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d(GC) - Association of Biotechnology and Pharmacy

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Current Trends in <strong>Biotechnology</strong> <strong>and</strong> <strong>Pharmacy</strong><br />

Vol. 6 (2) 196-203 April 2012, ISSN 0973-8916 (Print), 2230-7303 (Online)<br />

Table 2. Within <strong>and</strong> between batch precision <strong>and</strong> accuracy<br />

Acceptance criteria<br />

1) The within <strong>and</strong> between batch mean Precision for LQC, MQC <strong>and</strong> HQC samples should be within<br />

15% <strong>and</strong> 20% for the LOQ QC<br />

2) The within <strong>and</strong> between batch mean Accuracy for LQC, MQC <strong>and</strong> HQC samples should be within 85-<br />

115% <strong>and</strong> 80-120% for the LOQ QC<br />

QC ID LOQQC LQC MQC HQC<br />

Actual (ng/ml) 10.3129 28.2546 357.6527 861.8138<br />

QC-PA1 8.03635398 27.065301 356.704618 893.1308<br />

8.41787092 30.770766 342.647412 864.6573<br />

8.35451263 36.393436 361.322031 866.0097<br />

8.94058529 28.173236 357.13257 879.201<br />

9.02181804 29.208245 364.6488 833.9273<br />

8.96339905 29.028796 357.699024 811.64<br />

QC-PA2 9.7851 31.2179 322.2158 806.1628<br />

10.5656 33.7762 322.0735 707.4497<br />

9.8086 29.6063 325.5442 790.0107<br />

9.1712 29.3972 319.8673 727.5572<br />

9.4565 29.6731 314.3319 780.1988<br />

8.3166 23.9637 285.4347 665.0917<br />

QC-PA3 11.0094524 26.863036 345.577665 781.7984<br />

11.4023056 25.54112 365.126322 783.5845<br />

11.6242023 24.274589 362.855776 842.7417<br />

10.8603541 30.151343 338.160634 806.9359<br />

11.7378058 28.922102 352.064364 827.8195<br />

9.6742967 29.920648 354.000862 778.6509<br />

Mean 9.7304 29.1082 341.5226 802.5871<br />

SD 1.20344 3.04063 22.13759 59.85233<br />

%CV 12.37 10.45 6.48 7.46<br />

%Nominal 94.35 103.02 95.49 93.13<br />

5.<br />

assay for measurement <strong>of</strong> nitr<strong>of</strong>urantoin<br />

<strong>and</strong> its active metabolites: comparison with<br />

liquid chromatography-t<strong>and</strong>em mass<br />

spectrometry <strong>and</strong> micro particle enzymelinked<br />

immunoassay (MEIA-II). Clin Chem..<br />

44(12): 2516-23.<br />

Borrows, R., Chusney, G., Loucaidou, M et<br />

al. (2006). Clinical outcomes <strong>of</strong> renal<br />

transplantation using liquid<br />

chromatographic monitoring <strong>of</strong><br />

Nitr<strong>of</strong>urantoin in Human Plasma by using Liquid Chromatography / T<strong>and</strong>em Mass Spectrometry<br />

202<br />

6.<br />

nitr<strong>of</strong>urantoin. Ther Drug Monit.. 28(2): 269-<br />

73.<br />

Frank, S., Victor, W., Armstrong <strong>and</strong><br />

Michael, O. (2002). Rapid Liquid<br />

Chromatography–T<strong>and</strong>em Mass<br />

Spectrometry Routine Method for<br />

Simultaneous Determination <strong>of</strong> Losartan,<br />

Everolimus, Nitr<strong>of</strong>urantoin, <strong>and</strong><br />

Cyclosporine A in Whole Plasma, Clinical<br />

Chemistry. 48(6)

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