Chromatography Research International

Research Article

Development and Validation of Dissolution Test for Fluconazole Capsules by HPLC and Derivative UV Spectrophotometry

Table 1

Dissolution profiles for fluconazole determination: tested parameters and results.


Test	Time (min)	Medium	Medium volume (mL)	Apparatus	Rotation (rpm)	Average % dissolution	% R.S.D.

	5					39.05	10.58
	10					52.79	3.26
	15					55.73	3.14
1	20	water	900	Basket	100	56.73	1.16
	30					56.65	0.38
	45					56.82	0.31
	60					56.74	0.60
	65				150	56.69	1.11

	5					32.29	0.07
	10					48.09	4.78
	15					50.31	3.21
2	20	water	900	Paddle	75	51.01	2.02
	30					51.77	1.57
	45					52.48	1.25
	60					53.52	1.26
	65				150	56.99	0.89

	5					86.79	6.23
	10					94.14	3.47
	15					95.89	2.72
3	20	0.1 M HCl	900	Paddle	75	97.32	3.43
	30					98.64	2.40
	45					99.19	1.58
	60					98.24	1.68
	65				150	100.24	2.37

	5					85.45	9.69
	10					93.92	1.13
	15					95.70	0.26
4	20	0.1 M HCl	900	Paddle + sinker	75	96.63	0.73
	30					96.34	1.31
	45					97.06	1.71
	60					97.57	1.37
	65				150	100.00	1.43

	5					76.67	5.84
	10					86.41	1.35
	15					88.70	2.58
5	20	0.1 M HCl	900	Paddle	50	89.78	3.47
	30					90.44	3.65
	45					91.79	2.94
	60					92.36	3.81
	65				150	101.24	2.77

	5					58.10	4.62
	10					68.09	6.98
	15					71.54	7.02
6	20	0.1 M HCl	900	Paddle + sinker	50	73.34	5.75
	30					76.28	4.53
	45					78.76	4.70
	60					80.19	4.78
	65				150	99.05	4.55

	5					92.96	6.34
	10					98.96	0.32
	15					100.07	0.20
7	20	0.1 M HCl	900	Basket	100	100.56	0.39
	30					100.47	0.38
	45					98.09	0.15
	60					98.66	0.23
	65				150	98.92	0.87

	5					59.50	15.07
	10					82.07	4.45
	15					93.61	2.19
8	20	0.1 M HCl	900	Basket	75	97.00	1.93
	30					97.64	1.36
	45					96.43	1.35
	60					96.38	1.23