Direct Determination of ECD in ECD Kit: A Solid Sample Quantitation Method for Active Pharmaceutical Ingredient in Drug Product
Table 3
Precision and accuracy in the analysis of QC samples and ECD in ECD Kit.
Day
Standard curve(1)
Sulfur weight (%)(2)
Recovery yield (%)
Dynamic range of sulfur (mg)
Linear least squares regression equation
Correlation coefficient ()
QCcoal
QCcoal
QCECD (3)
1
0.033 –0.104
Y = 1.615 × 10−6X + 4.747 × 10−3
0.9993
3.13 ± 0.07 (2.25%)
102.08 ± 2.29
—
1
0.031–0.105
Y = 1.623 × 10−6X + 1.741 × 10−3
0.9989
3.10 ± 0.02 (0.60%)
100.89 ± 0.60
—
2
0.034–0.107
Y = 1.634 × 10−6X + 1.034 × 10−3
0.9994
3.08 ± 0.04 (1.21%)
100.15 ± 1.21
—
3
0.033–0.106
Y = 1.576 × 10−6X + 4.202 × 10−3
0.9996
3.18
103.79
102.78 (QC-L)
100.00 (QC-M)
102.08 (QC-H)
(1)Standard curves of coal. (2)Content percentage of sulfur in coal standard: 3.07% (w/w); data are expressed as average ± SD (%R.S.D.), . (3)Purity of ECD: 97.53%; compositions of ECD QC samples (QC-L, QC-M, and QC-H) were shown in Table 2.
