Chapter 7 Results
7. RESULTS
7.1 PREFORMULATION STUDY
7.1.1 Organoleptic Characteristics Organoleptic Characteristics was visually determined which was compliance with the standard. Table 7: Organoleptic characteristic of naproxen Sr.no Properties Standard Observed
1 Appearance White crystalline White crystalline
2 Odor Odorless Odorless
43 Taste Bitter Bitter
7.1.2 Melting Point of Naproxen Melting point was determined by Thiele?s tube method. Melting point of naproxen was found to be in the range of 154?C which was in compliance with the official value.
7.1.3 Solubility of Naproxen Solubility of naproxen in different
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weight of dry sample
% MC = Weight of water / Weight of dry sample ?100
And
% LOD = Weight of water / Weight of wet sample ?100
Percent loss on drying and moisture content was found to be 0.7% and 0.704% respectively.
7.1.5 Determination of Absorbance Maxima The naproxen shows the absorbance maxima at 305.6 nm in ethanol when the 10 ?g/ml solution was scanned at 200-400nm.
Figure 5: Absorbance Maxima of Naproxen
7.1.6 Preparation of Calibration Curve of Naproxen
In ethanol In this study Calibration curve was plotted Concentration Vs Absorbance by preparing dilution between the ranges of 2?g/ml-12?g/ml. Absorbance was determined range ?between? 0.078 to 0.443. Table 9: Concentration and Absorbance data for calibration curve Sr. No. Concentration (?g/ml) Absorbance (nm)
1 0 0
2 2 0.078
3 4 0.161
4 6 0.224
5 8 0.295
6 10 0.384
7 12 0.443
Figure 6: Calibration Curve of Naproxen in
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Table 12: interpretation of FTIR spectra of naproxen
Bonds Standard (/cm) Observed (/cm)
O-H stretch 3600-3500 3421.41
C=o stretch 1750 1740.39
C-O stretch 1100 1076.62
C=C stretch 1650-1550 1569.68
Comments for compatibility: All IR spectra of pure compound and its composition with excipients in formulation are same. This indicates that there was no structural change caused by excipients.
7.2 Optimization of Process Variable
The preparation procure was accordingly optimized and validated on the basis of following process variable Table 13: Effect of temperature Temperature Cholesterol
(mg)
Tween 80 (mg) Tween 20 (mg) Drug (mg) % Entrapment
40?C -60?C 50 100 100 50 Not Formed
Above 80?C 50 100 100 50 Color change
Table 14: Effect the concentration of cholesterol and drug Sr. no. Cholesterol
(mg)
Tween 80 (mg) Tween 20 (mg) Drug (mg) % Entrapment
1 50 100 100 100