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Dushyant Patel LC-MS/MS Method

S.K.P.C.P.E.R., Kherva 59 M .Pharm. Thesis

TABLE NO: 4.19

RECOVERY OF INTERNAL STANDARD (LEV) (IS AMOUNT 1.50 µg/ml)

4.3.8 Dilution integrity:

¾ Dilution integrity experiment was carried out at six replicate of two times diluted

2xULOQ (½ dilution) and four times diluted 2xULOQ (¼ dilution) samples. The

samples were prepared and its concentrations were calculated against the previously bulk

spiked calibration standards. The % CV for ½ dilutions and ¼ dilutions samples for GBP

were 3.76 and 2.88, respectively (Table No. 4.20). The mean % nominal concentration

for ½ dilutions and ¼ dilutions samples for GBP were 110.1 and 112.8, respectively

(Table No. 4.20)

TABLE NO: 4.20

DILUTION INTEGRITY OF GBP

Conc.

(µg/ml)

Dilution Area Ratio

Calculated

conc. (µg/ml)

% Nominal

Conc.

Mean SD %CV

12.000 1/4(2ULOQ) 2.314 13.22 110.1

112.8 3.25 2.88

12.000 1/4(2ULOQ) 2.366 13.52 112.7

12.000 1

4(2ULOQ) 2.345 13.40 111.6

12.000 1/4(2ULOQ) 2.471 14.12 117.6

12.000 1/4(2ULOQ) 2.294 13.10 109.2

12.000 1/4(2ULOQ) 2.429 13.87 115.6

Sr. No.

Area of LEV

Unextracted Extracted

1 5878075 6484337

2 5994692 6238048

3 6091646 6329058

4 6089236 6365513

5 5936550 6084339

6 6064166 6196985

7 5728743 6125954

8 5827817 6358164

9 5797186 6069732

10 5811422 6130189

11 5929188 6246940

12 5758359 6169999

13 5770043 6046114

14 5955326 6043754

15 5935133 6111543

16 5850428 6231866

17 5829306 5795219

18 5970797 5960257

n 18 18

Mean 5901006 6166001

SD 113183 163172

%CV 1.92 2.65

%Recovery 104.5

1 2 ... 66 67 68 69 70 71 72 73 74 75 76 ... 92 93

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