|
Glimepiride |
Type of stability |
t
(month) |
Disintegration time( s ) |
Avarage weight( mg ) |
Hardness
( kp ) |
Friability( % ) |
*Dissolution rate ( % ) |
Amount(mg/ tablet) |
| G1 (Measured) |
Accelerated |
0 |
70.330 |
85.096 |
7.000 |
0.959 |
84.534 |
0.878 |
| 6 |
47.220 |
84.766 |
6.500 |
0.460 |
68.895 |
0.802 |
| Long term |
0 |
70.330 |
85.096 |
7.000 |
0.960 |
82.406 |
0.878 |
| 3 |
50.900 |
85.766 |
7.000 |
0.251 |
84.259 |
0.713 |
| 6 |
48.300 |
84.520 |
6.500 |
1.254 |
80.555 |
0.792 |
| G2(Calculated) |
Accelerated |
0 |
109.460 |
120.000 |
8.760 |
0.280 |
105.140 |
1.560 |
| 6 |
106.370 |
120.000 |
8.220 |
0.310 |
96.950 |
1.430 |
| Long term |
0 |
109.460 |
120.000 |
8.760 |
0.280 |
105.140 |
1.560 |
| 3 |
107.270 |
120.000 |
8.640 |
0.440 |
104.760 |
1.500 |
| 6 |
105.080 |
110.000 |
8.500 |
0.600 |
104.380 |
1.450 |
| G3(Calculated) |
Accelerated |
0 |
141.610 |
140.000 |
10.580 |
0.180 |
103.140 |
2.610 |
| 6 |
138.520 |
140.000 |
10.030 |
0.220 |
94.950 |
2.490 |
| Long term |
0 |
141.610 |
140.000 |
10.580 |
0.180 |
103.140 |
2.610 |
| 3 |
139.420 |
140.000 |
10.450 |
0.540 |
102.760 |
2.550 |
| 6 |
137.220 |
140.000 |
10.320 |
0.300 |
102.380 |
2.500 |
| G4 (Measured) |
Accelerated |
0 |
150.330 |
167.066 |
13.000 |
0.172 |
85.494 |
3.882 |
| 6 |
164.900 |
167.300 |
12.000 |
0.422 |
83.178 |
3.690 |
| Long term |
0 |
150.500 |
167.066 |
13.000 |
0.188 |
85.494 |
3.910 |
| 3 |
166.300 |
167.133 |
11.500 |
0.213 |
85.340 |
3.813 |
| 6 |
162.30 |
166.80 |
12.5 |
0.531 |
84.260 |
3.765 |
| **
correlation coefficiency ( r2) |
|
|
0.9804 |
0.9996 |
0.9832 |
0.4085 |
0.5938 |
0.9986 |
| ***F(calculated) |
|
|
238.079 |
12086.627 |
423.224 |
3.280 |
6.943 |
3288.504 |
| p |
|
|
0.000 |
0.000 |
0.000 |
0.033 |
0.001 |
0.000 |
*amount of active substance released at 15 minute
**correlation coefficient values of all quality control parameters.
*** F: Degrees of freedom |