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Dushyant Patel LC-MS/MS Method

S.K.P.C.P.E.R., Kherva 60 M .Pharm. Thesis

Table No. 4.20 continue

12.000 1/2(2ULOQ) 4.788 13.68 114.0

110.1 4.14 3.76

12.000 1/2(2ULOQ) 4.753 13.58 113.2

12.000 1/2(2ULOQ) 4.790 13.69 114.1

12.000 1/2(2ULOQ) 4.398 12.57 104.7

12.000 1/2(2ULOQ) 4.478 12.80 106.6

12.000 1/2(2ULOQ) 4.539 12.97 108.1

Underlined Values were outside the acceptance criteria of 85 - 115 % of their Nominal concentration.

4.3.9 Matrix effect:

¾ In order to ensure the effect of matrix through out the application of the method, plasma

blanks obtained from six different lots (04 normal Heparinised, 01 lipemic and 01

Haemolysed) were spiked with GBP and LEV at LQC and HQC level. Three quality

control samples at each level along with the set of calibration standards were analyzed

and the % nominal concentration of the samples analyzed was represented in Table No.

4.21 for GBP.

TABLE NO: 4.21

MATRIX EFFECT FOR GBP

Sample ID

Area

Area Ratio

Calculated

Conc. (µg/ml)

% Nominal

Conc.

GBP LEV

LQC (B225-08) 650607 5282209 0.123 0.158 105.3

LQC (B225-08) 545422 5387477 0.101 0.129 86.00

LQC (B225-08) 640750 5168602 0.124 0.159 106.0

LQC (B233-08) 610622 5748937 0.106 0.136 90.67

LQC (B233-08) 676296 5442613 0.124 0.159 106.0

LQC (B233-08) 597559 5371499 0.111 0.142 94.67

LQC (B235-08) 640966 5194270 0.123 0.158 105.3

LQC (B235-08) 626810 5188691 0.121 0.155 103.3

LQC (B235-08) 649784 5296223 0.123 0.157 104.7

LQC (B257-08) 635371 5269874 0.121 0.154 102.7

LQC (B257-08) 605975 5167406 0.117 0.150 100.0

LQC (B257-08) 619823 5085894 0.122 0.156 104.0

LQC (C001-08) 613001 5082831 0.121 0.154 102.7

LQC (C001-08) 615736 5268006 0.117 0.149 99.32

LQC (C001-08) 626823 5246560 0.119 0.153 102.0

LQC (D001-08) 600304 5033638 0.119 0.153 102.0

LQC (D001-08) 599510 5132926 0.117 0.149 99.33

LQC (D001-08) 620307 5208218 0.119 0.152 101.3

HQC (B225-08) 17133637 5141557 3.332 4.333 96.29

HQC (B225-08) 17359078 5108035 3.398 4.419 98.20

HQC (B225-08) 17579091 5219371 3.368 4.380 97.33

HQC (B233-08) 17464700 5104934 3.421 4.449 98.87

HQC (B233-08) 17903117 5278421 3.392 4.410 98.00

HQC (B233-08) 17661794 5241003 3.370 4.382 97.38

HQC (B235-08) 10326750 5233174 1.973 2.565 57.00

HQC (B235-08) 17417496 5151214 3.381 4.397 97.71

HQC (B235-08) 18019725 5319023 3.388 4.405 97.89

1 2 ... 67 68 69 70 71 72 73 74 75 76 77 ... 92 93

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