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Dushyant Patel LC-MS/MS Method

S.K.P.C.P.E.R., Kherva 65 M .Pharm. Thesis

Table No. 4.28 continue

Sr. No.

HQC (4.50 µg/ml)

Comparison samples Stability samples

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

1 4.536 100.8 2.463 54.73

2 4.583 101.8 4.132 91.82

3 4.610 102.4 4.197 93.27

4 4.567 101.5 4.361 96.91

5 4.627 102.8 4.283 95.18

6 4.476 99.47 4.029 89.53

n 6

Mean 4.567 3.911

% Mean Change -14.36

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

4.3.10.5 Freeze and thaw stability of GBP (after 4th cycle at -70°C):

¾ Samples were prepared at LQC and HQC levels, aliquoted and frozen at -70°C. Six

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

(stability samples). These samples were processed after 4

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.

GBP was found to be stable in LQC and HQC samples after 4th cycle at -70°C with %

mean change of -5.71 and -6.07, respectively (Table No.4.29).

TABLE NO: 4.29

FREEZE AND THAW STABILITY OF GBP (after 4th cycle at -70°C)

Sr.

No.

LQC (0.15 µg/ml)

Comparison samples Stability samples

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

1 0.146 103.3 0.155 103.3

2 0.151 90.00 0.135 90.00

3 0.155 100.0 0.150 100.0

4 0.154 88.00 0.132 88.00

5 0.149 101.3 0.152 101.3

6 0.156 90.00 0.135 90.00

n 6

Mean 0.152 0.143

% Mean Change -5.71

Sr.

No.

HQC (4.50 µg/ml)

Comparison samples Stability samples

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

1 4.536 100.8 4.259 94.64

2 4.583 101.8 4.251 94.47

3 4.610 102.4 4.259 94.64

4 4.567 101.5 4.396 97.69

5 4.627 102.8 4.321 96.02

6 4.476 99.47 4.249 94.42

n 6

Mean 4.567 4.289

% Mean Change -6.07

1 2 ... 72 73 74 75 76 77 78 79 80 81 82 ... 92 93

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