d(GC) - Association of Biotechnology and Pharmacy

Current Trends in Biotechnology and Pharmacy
Vol. 6 (2) 196-203 April 2012, ISSN 0973-8916 (Print), 2230-7303 (Online)
Table 1. Curve parameter summary and back-calculated calibration curve concentration for Nitrofurantoin in human Plasma
STANDARD (CC ID) A B C D E F G H I
ACTUAL (NG/ML) 10.2483 25.6209 51.2417 102.4835 256.2086 457.5154 667.9057 861.8138 1013.8986
CC1(P &A 1) 9.005733337 26.9988858 52.4 4977771 105.372637 270.932378 437 .078142 703.6463876 762.3971 521 1078.044345
CC2(P &A 2) 10.50949 324.6 9850 649.650613 105.233318 269.1729 69 435.934921 682.8 839761 837. 077386 1032. 090417
CC3(P & A 3) 11.1994415 123. 60441 646. 42190002 109 .828 016 265.539938 440. 858154 67 9.4623121 842.5 262955 1027.5 47215
MEAN 10.2382 25.100 649.5074 106. 8113 268.5484 4 37.9571 688.6642 814.0003 10 45.894
SD 1.12173 1.73259 3.01649 2.6134 6 2.74993 2.57661 13.08724 44.93553 27.93553
%CV 10.96 6.9 6.09 2.45 1.02 0.59 1.9 5.5 2.67
%NOMINAL 99 .9 97.97 96.62 104.22 104. 82 95.73 103.11 94.45 103.16
Acceptance Criteria: 1) Precision for all CC std 1-9 should be within 15% and for LOQ should be within 20%.
2) Accuracy for all CC std 1-9 should be within 85-115% and for LOQ should be within 80-120%.
Note:- a - Standard was not considered for calculation.
NA- Not Applicable
Rajaram S. Patil et al
201
Recovery: The absolute recovery was
calculated by comparing the peak areas of
Nitrofurantoin and Losartan standards to those
assessed by extraction of Nitrofurantoin and
Losartan at the three different concentrations.
Results of absolute recovery of Nitrofurantoin
and Losartan were 103.160% and 94.889%
respectively as shown in Table 2.
Conclusion
This method was validated in human
Plasma for its specificity, sensitivity, linearity,
accuracy, precision (repeatability &
reproducibility), % recovery, stability of samples
(Freeze thaw, Bench top and Auto sampler
stability, short-term and long term stability of stock
solution and Internal Standard), dilution integrity
and for ruggedness. Method is applicable to
quantify the Nitrofurantoin in clinical samples for
further evaluation of pharmacokinetics.
Acknowledgement
The author would like to thank
Dr.S.S.Makone and Dr.Vinay P. Shedbalkar for
their continuous encouragement and remarks.
References
1. Alak, A.M., Moy, S., Cook, M. et al. (1997).
An HPLC/MS/MS assay for Nitrofurantoin
in patient Plasma samples. Correlation with
results of an ELISA assay. J Pharm Biomed
Anal.. 16(1): 7-13.
2. Alak, A.M., Cook, M. and Bekersky, I.
(1997). A highly sensitive enzyme-linked
immunosorbent assay for the determination
of nitrofurantoin in atopic dermatitis
patients. Ther Drug Monit.. 19(1): 88-91.
3. Alak AM. (1997). Measurement of
nitrofurantoin (FK506) and its metabolites:
a review of assay development and
application in therapeutic drug monitoring
and pharmacokinetic studies. Ther Drug
Monit.. 19(3): 338-51.
4. Armstrong, V.W., Schuetz, E., Zhang, Q et
al. (1998). Modified pentamer formation