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Dushyant Patel LC-MS/MS Method

S.K.P.C.P.E.R., Kherva 53 M .Pharm. Thesis

4.3.2 Specificity and selectivity:

¾ Four different lots of heparinised plasma, one lot of lipemic plasma and one lot of

heamolysed plasma were chromatographed and no area response observed at the RT of

GBP and no area response at the RT of IS (Table No. 4.11).

TABLE NO: 4.11

SPECIFICITY AND SELECTIVITY OF BLANK HUMAN PLASMA FOR GBP AND LEV

Sr.

No.

Sample Name

Area % of area

GBP LEV GBP LEV

1 BLANK PLASMA(B225-08)

F 0.0 0.0

2 LLOQ(B225-08) 161694 4789031

3 BLANK PLASMA(B233-08) NF NF 0.0 0.0

4 LLOQ(B233-08) 156619 4865603 NA NA

5 BLANK PLASMA(B235-08) NF NF 0.0 0.0

6 LLOQ(B235-08) 168187 4516163 NA NA

7 BLANK PLASMA(B257-08) NF NF 0.0 0.0

8 LLOQ(B257-08) 155397 4764312 NA NA

9 BLANK PLASMA(C001-08) NF NF 0.0 0.0

10 LLOQ(C001-08) 161691 4727598 NA NA

11 BLANK PLASMA(D001-08) NF NF 0.0 0.0

12 LLOQ(D001-08) 155965 4653627 NA NA

NA: Not Applicable, NF: Not Found

4.3.3 Sensitivity:

¾ The LLOQ was 0.05 µg/ml for GBP. The % CV of GBP at LLOQ was found to be 9.60.

The % nominal concentration for LLOQ samples of GBP was 96.33 (Table No.4.12).

TABLE NO: 4.12

SENSITIVITY (LLOQ OF GBP)

Sr.

No.

Sample Name

Conc. Area

Area Ratio

Calculated

% Nominal conc.

(µg/ml) GBP LEV Conc. (µg/ml)

1 LLOQ 0.05 196834 5711167 0.034 0.049 98.00

2 LLOQ 0.05 152127 5403757 0.028 0.040 80.00

3 LLOQ 0.05 195501 5744727 0.034 0.049 98.00

4 LLOQ 0.05 187094 5648930 0.033 0.047 94.00

5 LLOQ 0.05 200096 5738419 0.035 0.050 100.0

6 LLOQ 0.05 218511 5801135 0.038 0.054 108.0

Mean 0.048 96.33

SD 0.005

%CV 9.60

4.3.4 Linearity:

¾ The Linearity of the method was determined by a weighted least square linear regression

analysis of standard plots associated with a nine-point standard calibration curve. Best-fit

calibration curves of peak area ratio versus concentration were drawn. The calibration

curves were linear from 0.05 µg/ml to 6.00 µg/ml with correlation coefficient of r

≥

0.9976 for GBP (Table No. 4.13 and 4.14, Figure 4.13).

1 2 ... 60 61 62 63 64 65 66 67 68 69 70 ... 92 93

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