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Dushyant Patel LC-MS/MS Method

S.K.P.C.P.E.R., Kherva 55 M .Pharm. Thesis

4.3.5 Accuracy:

Within-batch or intra-batch accuracy:

¾ The % nominal concentration for LLOQ, LQC, MQC and HQC samples of GBP were

found 96.33, 105.0, 104.9 and103.9, respectively (Table No. 4.15).

Between -batch or inter-batch accuracy:

¾ The % nominal concentration for LLOQ, LQC, MQC and HQC samples of GBP were

found 99.00, 101.7, 101.4 and 101.6, respectively (Table No. 4.16).

4.3.6 Precision:

Within-batch or intra-batch precision:

¾ The % CV for LLOQ, LQC, MQC and HQC samples of GBP were 9.60, 4.54, 2.11 and

2.14, respectively (Table No. 4.15).

Between -batch or inter-batch precision:

¾ The % CV for LLOQ, LQC, MQC and HQC samples of GBP were 7.90, 3.38, 4.88 and

2.73, respectively. (Table No. 4.16).

TABLE NO: 4.15

WITHIN-BATCH OR INTRA-BATCH ACCURACY AND PRECISION OF GBP

Sr.

No.

LLOQ (0.05 µg/ml) LQC (0.15 µg/ml)

Calculated conc. % Nominal conc. Calculated conc. % Nominal conc.

1 0.049 98.00 0.163 108.7

2 0.040 80.00 0.166 110.7

3 0.049 98.00 0.154 102.7

4 0.047 94.00 0.162 108.0

5 0.050 100.0 0.148 98.67

6 0.054 108.0 0.152 101.3

n 6 6

Mean 0.048 96.33 0.158 105.0

SD 0.005

0.007

%CV 9.60 4.54

Sr.

No.

MQC (2.00 µg/ml) HQC (4.50 µg/ml)

Calculated conc. % Nominal conc. Calculated conc. % Nominal conc.

1 2.103 105.1 4.726 105.0

2 2.172 108.6 4.803 106.7

3 2.092 104.6 4.619 102.6

4 2.094 104.7 4.734 105.2

5 2.088 104.4 4.636 103.0

6 2.034 101.7 4.523 100.5

n 6 6

Mean 2.097 104.9 4.674 103.9

SD 0.044

0.100

%CV 2.11 2.14

1 2 ... 62 63 64 65 66 67 68 69 70 71 72 ... 92 93

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Samsung RT34M Manuale Utente Pagina 67

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