Samsung RT34M Instrukcja Użytkownika Pobierz pdf (Strona 76)

Dushyant Patel LC-MS/MS Method

S.K.P.C.P.E.R., Kherva 64 M .Pharm. Thesis

TABLE NO: 4.27

PROCESS STABILITY OF GBP (at 5°C in auto sampler for 76 hrs)

Sr. No.

LQC (0.15 µg/ml)

Comparison samples Stability samples

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

1 0.147 98.00 0.149 99.33

2 0.150 100.0 0.153 102.0

3 0.153 102.0 0.154 102.7

4 0.153 102.0 0.157 104.7

5 0.153 102.0 0.152 101.3

6 0.152 101.3 0.150 100.0

n 6

Mean 0.151 0.153

% Mean Change 0.77

Sr. No.

HQC (4.50 µg/ml)

Comparison samples Stability samples

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

1 4.407 97.93 4.625 102.8

2 4.418 98.18 4.602 102.3

3 4.275 95.00 4.720 104.9

4 4.346 96.58 4.769 105.9

5 4.513 100.3 4.546 101.2

6 4.415 98.11 4.548 101.1

n 6

Mean 4.396 4.635

% Mean Change 5.44

4.3.10.4 Freeze and thaw stability of GBP (after 4th cycle at -20°C):

¾ Samples were prepared at LQC and HQC levels, aliquoted and frozen at -20°C. Six

samples from each concentration were subjected to three freeze and thaw cycles

(stability samples). These samples were processed after 4th cycle and analyzed along

with previously bulk spiked calibration standards, LQC and HQC samples (comparison

samples). Concentrations were calculated to determine % mean change after 4th

cycle.

¾ GBP was found to be stable in LQC and HQC samples after 4th cycle at -20°C with %

mean change of 0.00 and -14.36, respectively (Table No. 4.28).

TABLE NO: 4.28

FREEZE AND THAW STABILITY OF GBP (after 4th cycle at -20°C)

Sr. No.

LQC (0.15 µg/ml)

Comparison samples Stability samples

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

1 0.146 97.33 0.158 105.3

2 0.151 100.7 0.150 100.0

3 0.155 103.3 0.150 100.0

4 0.154 102.7 0.152 101.3

5 0.149 99.33 0.148 98.67

6 0.156 104.0 0.151 100.7

n 6

Mean 0.152 0.152

% Mean Change 0.00

1 2 ... 71 72 73 74 75 76 77 78 79 80 81 ... 92 93

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