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Current Trends in Biotechnology and Pharmacy Vol. 6 (2) 196-203 April 2012, ISSN 0973-8916 (Print), 2230-7303 (Online) Nitrofurantoin in Human Plasma by using Liquid Chromatography / Tandem Mass Spectrometry 200
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
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6th Annual Convention of Associatio
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