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Dushyant Patel LC-MS/MS Method

S.K.P.C.P.E.R., Kherva 66 M .Pharm. Thesis

4.3.11 Carry over check for GBP:

¾ No area response was observed or area response less than 20% and 5% of mean response

of an extracted LLOQ standard was observed at the RT of analyte and internal standard

(IS), respectively, in respective blank matrix and or blank solution (Table No. 4.30).

TABLE NO: 4.30

CARRY OVER CHECK FOR GBP

Sr.

No.

Sample Name

Area

Area Ratio

Calculated

Conc.

(µg/ml)

GBP LEV

1 EXTRACTED LLOQ 246416 6634503 0.037 0.051

2 EXTRACTED LLOQ 244374 6736462 0.036 0.049

3 BLANK PLASMA NF NF NA NA

4 EXTRACTED ULOQ 27080421 6731495 4.023 6.036

5 BLANK PLASMA NF NF NA NA

6 EXTRACTED ULOQ 27496928 6883295 3.995 5.994

7 BLANK PLASMA NF NF NA NA

4.4 REFERENCES:

1. Chapman JR. Practical Organic Mass Spectrometry. 2

ed. Wiley, London; 1993.

2. McLafferty FW, Turecek, F. Interpretation of Mass Spectra. 4

ed. University science

Books, Mill Valley, C.A.; 1993.

3. Lambert JB, Shurvell HF, Lighter D, Cooks RG. Introduction to Organic Spectroscopy.

MacMillan Publishing, New York; 1987: p.313.

4. Hoffmann E, Charette J, Stroobant V. Mass Spectrometry: Principles and Applications.

Wiley, London; 1996.

5. Nibbering NMM. J Chromatogr 1982 ; 251, 93.

6. Niessen WMA, Nibbering M. Liquid Chromatography-Mass Spectrometry. 2

ed.

Marcell Decker Inc, New York; 1999: p. 43-51.

7. March RE. J Mass Spectrom 1995; 30:1519.

8. Schlag EW. Time-of –Flight Mass Spectrometry and its application. Elsevier,

Amsterdam; 1994.

9. Brunnee C. Int J Mass Spectrom Ion Proc 1987; 76: 125.

10. Yang L, Amad M, Winnik WM, Schoen AE, Schweingruber H, Mylchreest I, Rudewicz

PJ. Rapid Commun Mass Spectrom 2002; 16: 2060.

11. McLafferty FW. Tandem Mass Spectrometry. Wiley, New York; 1983.

12. Talroze VL, Skurat VE, Gorodetskii IG, Zolotai NB. Russ J Phys Chem 1972; 46: 456.

13. Talroze VL, Skurat VE, Karpov GV. Russ J Phys Chem 1969; 43: 241.

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