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and then makeup with mobile phase and sonicate for The stock solutions equivalent to 20ppm to 80ppm
10min. with respect to both drugs were prepared in
Preparation of working standard solution: combination of Naproxen and Esomeprazole above,
sonicated and filtered through 0.45µ membrane.
4.128
0.060
0.050
0.040
AU
0.030
0.020
0.010
0.000
0.35
0.30
0.25
4.027
0.20
AU
0.15
0.10
0.05
0.00
0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 5.50 6.00 6.50 7.00
Minutes
0.060
2.950
3.591
0.050
0.040
AU
0.030
0.020
0.010
0.000
0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 5.50 6.00
Minutes
OPTIMIZED METHOD
0.18
Esomeprazole - 3.538
0.16
0.10
AU
0.08
0.06
0.04
0.02
0.00
0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 5.50 6.00 6.50 7.00
Minutes
2 Esomeprazole 3.532
0.18
Esomeprazole - 3.532
0.16
Naproxen - 2.955
0.14
0.12
0.10
AU
0.08
0.06
0.04
0.02
0.00
0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 5.50 6.00 6.50 7.00
Minutes
Fig5:Chromatogram of sample
2 Esomeprazole 3.532
TABLE- 3(a): Data of System Suitability forNaproxen
Injection RT Peak Area USP Plate count USP Tailing
1 2.869 1139272 5890.964069 1.238915
2 2.868 1140892 5915.423628 1.230637
3 2.872 1136301 5934.796986 1.240858
4 2.868 1141067 5976.253744 1.238995
5 2.872 1136024 5953.814152 1.241073
Mean 2.873218 1138711 5934.251 1.236496
SD 0.000837 57540.015 ------- -------
% RSD 0.028363 0.213538 ------- -------
0.16
Naproxen - 2.955
0.14
0.12
0.10
AU
0.08
0.06
0.04
0.02
0.00
0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 5.50 6.00 6.50 7.00
Minutes
0.18
Esomeprazole - 3.525
0.16
Naproxen - 2.954
0.14
0.12
0.10
AU
0.08
0.06
0.04
0.02
0.00
0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 5.50 6.00 6.50 7.00
Minutes
Esomeprazole - 3.523
0.16
Naproxen - 2.953
0.14
0.12
0.10
AU
0.08
0.06
0.04
0.02
0.00
0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 5.50 6.00 6.50 7.00
Minutes
0.16
Naproxen - 2.953
0.14
0.12
0.10
AU
0.08
0.06
0.04
0.02
0.00
0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 5.50 6.00 6.50 7.00
Minutes
0.18
Esomeprazole - 3.535
0.16
Naproxen - 2.955
0.14
0.12
0.10
AU
0.08
0.06
0.04
0.02
0.00
0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 5.50 6.00 6.50 7.00
Minutes
0.18
Esomeprazole - 3.523
0.16
Naproxen - 2.953
0.14
0.12
0.10
AU
0.08
0.06
0.04
0.02
0.00
0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 5.50 6.00 6.50 7.00
Minutes
Esomeprazole - 3.545
0.070
Naproxen - 2.960
0.060
0.050
0.040
AU
0.030
0.020
0.010
0.000
0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 5.50 6.00 6.50 7.00
Minutes
0.16
Naproxen - 2.955
0.14
0.12
0.10
AU
0.08
0.06
0.04
0.02
0.00
0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 5.50 6.00 6.50 7.00
Minutes
0.25
Naproxen - 2.953
0.20
0.15
AU
0.10
0.05
0.00
0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 5.50 6.00 6.50 7.00
Minutes
2000000
y = 31282x + 11218.
1500000 R² = 0.999
1000000 Series1
Linear (Series1)
500000
0
0 20 40 60 80 100
0.070
Esomeprazole - 3.547
Naproxen - 2.960
0.060
0.050
0.040
AU
0.030
0.020
0.010
0.000
0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 5.50 6.00 6.50 7.00
Minutes
Esomeprazole - 3.547
0.12
0.10
Naproxen - 2.959
0.08
AU
0.06
0.04
0.02
0.00
0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 5.50 6.00 6.50 7.00
Minutes
0.18
Esomeprazole - 3.538
0.16
Naproxen - 2.955
0.14
0.12
0.10
AU
0.08
0.06
0.04
0.02
0.00
0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 5.50 6.00 6.50 7.00
Minutes
Esomeprazole - 3.537
0.20
0.15
AU
0.10
0.05
0.00
0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 5.50 6.00 6.50 7.00
Minutes
Fig 19: Chromatograms for 50 ppm
Esomeprazole - 3.536
0.25
Naproxen - 2.952
0.20
0.15
AU
0.10
0.05
0.00
0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 5.50 6.00 6.50 7.00
Minutes
0.16
Naproxen - 2.955
0.14
0.12
0.10
AU
0.08
0.06
0.04
0.02
0.00
0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 5.50 6.00 6.50 7.00
Minutes
Esomeprazole - 4.412
0.16
Naproxen - 3.675
0.14
0.12
0.10
AU
0.08
0.06
0.04
0.02
0.00
0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 5.50 6.00 6.50 7.00
Minutes
0.16
Naproxen - 2.953
0.14
0.12
0.10
AU
0.08
0.06
0.04
0.02
0.00
0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 5.50 6.00 6.50 7.00
Minutes
Esomeprazole - 2.946
Naproxen - 2.465
0.12
0.10
0.08
AU
0.06
0.04
0.02
0.00
0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 5.50 6.00 6.50 7.00
Minutes
4. SUMMARY AND CONCLUSION: 2. Gralnek IM, Dulai GS, Fennerty MB, Spiegel BM
The analytical method was developed by studying (December 2006). "Esomeprazole versus other proton
different parameters. First of all, maximum pump inhibitors in erosive esophagitis: a meta-
absorbance was found to be at 332nm Naproxen for analysis of randomized clinical trials". Clin.
and 285nm for Esomeprazole. Common wavelength Gastroenterol. Hepatol. 4 (12): 1452–8.
will be 272nm and the peaks purity was excellent. doi:10.1016/j.cgh.2006.09.013. PMID 17162239.
Injection volume was selected to be 20µl which gave 3.Edwards SJ, Lind T, Lundell L (September 2006).
a good peak area. The column used for study was "Systematic review: proton pump inhibitors (PPIs)
Inertsil C18, ODS chosen good peak shape. Ambient for the healing of reflux oesophagitis - a comparison
temperature was found to be suitable for the nature of of esomeprazole with other PPIs". Aliment.
drug solution. The flow rate was fixed at 1.0ml/min Pharmacol. Ther. 24 (5): 743–50. doi:10.1111/j.1365-
because of good peak area, satisfactory retention time 2036.2006.03074.x. PMID 16918878.
and good resolution. Different ratios of mobile phase 4. "Nexium side effects". Drug information online.
were studied, mobile phase with ratio of 45:55 Drugs.com. Retrieved 2009-06-23.
Methanol : Buffer was fixed due to good symmetrical 5. Yang YX, Lewis JD, Epstein S, Metz DC (2006).
peaks and for good resolution. So this mobile phase "Long-term proton pump inhibitor therapy and risk of
was used for the proposed study. hip fracture". JAMA 296 (24): 2947–53.
The present recovery was found to be 98.0-101.50 doi:10.1001/jama.296.24.2947. PMID 17190895.
was linear and precise over the same range. Both 6. "Proton pump inhibitors and Clostridium difficile".
system and method precision was found to be Bandolier. 2003. Retrieved 2007-07-13.
accurate and well within range. Detection limit was 7. Herzig SJ, Howell MD, Ngo LH, Marcantonio ER
found to be 0.25 Naproxen and 0.52 for (2009). "Acid-suppressive medication use and the
Esomeprazole. Linearity study was, correlation risk for hospital-acquired pneumonia". JAMA 301
coefficient and curve fitting was found to be. The (20): 2120–8. doi:10.1001/jama.2009.722. PMID
analytical method was found linearity over the range 19470989.
of 20-80ppm of the target concentration for both the 8. Stedman CA, Barclay ML (August 2000). "Review
drugs. The analytical passed both robustness and article: comparison of the pharmacokinetics, acid
ruggedness tests. On both cases, relative standard suppression and efficacy of proton pump inhibitors".
deviation was well satisfactory. Aliment. Pharmacol. Ther. 14 (8): 963–78.
doi:10.1046/j.1365-2036.2000.00788.x. PMID
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