Development of a Gradient HPLC Method for the Simultaneous Determination of Sotalol and Sorbate in Oral Liquid Preparations Using Solid Core Stationary Phase

Table 3

Validation parameters of formulations F1–F5.

	F1		F2		F3		F4		F5		Criterion
	SOT	SORB	SOT	SORB	SOT	SORB	SOT	SORB	SOT	SORB
Repeatability (% R.S.D.)^a	0.00	0.00	0.00	0.00	0.00	0.00	0.00	0.00	0.00	0.00
Repeatability area (% R.S.D.)^a	0.22	0.57	0.22	0.57	0.22	0.57	0.22	0.57	0.22	0.57
Theoretical plates per meter	11,810	282,650	11,810	282,650	11,810	282,650	11,810	282,650	11,810	282,650	—
Resolution^a	—	18.39	—	18.39	—	18.39	—	18.39	—	18.39
Tailing factor^a	1.10	1.23	1.10	1.23	1.10	1.23	1.10	1.23	1.10	1.23	= 0.8–1.5
Precision (% R.S.D.)^b	0.43	—	0.16	—	0.49	0.98	0.26	1.51	0.21	1.11
Linearity (correlation coefficient)^c	0.9995	0.9995	0.9995	0.9995	0.9995	0.9995	0.9995	0.9995	0.9995	0.9995
Accuracy recovery (%)^b	101.09	—	99.57	—	99.59	98.26	99.93	98.70	99.35	98.57
Accuracy (% R.S.D.)^b	0.58	—	0.85	—	1.44	2.27	0.71	2.07	0.57	1.14
Selectivity	No interference		No interference		No interference		No interference		No interference		No interference

Six injections.
^bSix samples, three injections of each sample.
^cAt 50, 75, 100, 134, 166, and 200% concentration levels.
SOT: sotalol hydrochloride.
SORB: potassium sorbate.
Fx: formulations with various excipients.
% R.S.D.: relative standard deviation in %.