Samsung RT34M Uživatelský manuál stáhnout pdf (Strana 75)

Dushyant Patel LC-MS/MS Method

S.K.P.C.P.E.R., Kherva 63 M .Pharm. Thesis

spiked calibration standards, LQC and HQC samples. Concentrations were calculated to

determine % mean change during stability period.

¾ GBP was found to be stable in LQC and HQC samples for 20 Hrs at room temperature

with % mean change of 4.17 and 3.71, respectively (Table No. 4.26).

TABLE NO: 4.26

BENCH TOP STABILITY OF GBP (20 hrs at room temp.)

Sr. No.

LQC (0.15 µg/ml)

Comparison samples Stability samples

Sample conc. % Nominal Conc. Sample conc. % Nominal Conc.

1 0.147 98.00 0.160 106.7

2 0.149 99.33 0.151 100.7

3 0.149 99.33 0.156 104.0

4 0.145 96.67 0.156 104.0

5 0.151 100.7 0.157 104.7

6 0.146 97.33 0.144 96.00

n 6

Mean 0.148 0.154

% Mean Change 4.17

Sr. No.

HQC (4.50 µg/ml)

Comparison samples Stability samples

Sample conc. % Nominal Conc. Sample conc. % Nominal Conc.

1 4.477 99.49 4.550 101.1

2 4.535 100.8 4.639 103.1

3 4.458 99.07 4.724 104.9

4 4.587 101.9 4.896 108.8

5 4.745 105.4 4.935 109.7

6 4.655 103.4 4.733 105.2

n 6

Mean 4.576 4.746

% Mean Change 3.71

4.3.10.3 Process stability of GBP (at 5°C in auto sampler for 76 hrs):

¾ LQC and HQC samples were prepared and processed. These processed samples were

kept in auto sampler for 76 hrs at 5°C, these samples were analyzed along with

previously bulk spiked calibration standards, LQC and HQC samples concentrations

were calculated to determine % mean change during stability period.

¾ GBP was found to be stable in LQC and HQC samples for 76 hrs at 5°C in auto sampler

with % mean change of 0.77 and 5.44, respectively (Table No. 4.27).

1 2 ... 70 71 72 73 74 75 76 77 78 79 80 ... 92 93

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