Chromatographic analysis of triple cough therapy; bromhexine, guaiafenesin and salbutamol and pharmaceutical impurity: in-silico toxicity profile of drug impurity

Table 3 Regression and validation parameters of the proposed methods for determination of guaiafenesin, bromhexine, salbutamol and guaiacol

Parameters	TLC				HPLC
Parameters	GUF	BR	SAL	GUL	GUF	BR	SAL	GUL
Calibration range	0.50–8.00 μg/band	0.25–4.00 μg/band	0.25–4.00 μg/band	0.10–1.60 μg/band	2.00–50.00 μg/mL
Slope	1615.60	2779.20	1556.40	3723.30	0.2082	0.1328	0.1428	0.2031
Intercept	2547.20	2426.00	716.89	733.65	− 0.0560	− 0.1091	0.0907	− 0.3102
Correlation coefficient (r²)	0.9998	0.9998	0.9999	0.9999	0.9999	0.9999	0.9999	0.9999
Accuracy (%R)	98.59	99.84	99.76	99.82	99.77	99.83	99.09	99.20
Repeatability (%RSD)^a	0.79	0.71	0.93	0.39	1.42	0.87	1.27	1.47
Intermediate precision(%RSD)^a	1.00	0.81	1.32	0.99	1.77	1.04	1.34	1.54
LOD^b	0.16	0.07	0.08	0.02	0.56	0.61	0.51	0.59
LOQ^c	0.48	0.21	0.24	0.06	1.70	1.83	1.53	1.78

Where SD is the standard deviation of the intercept and slope is the slope of the calibration graph
^aThe intra-day and inter-day precision (n = 9), %RSD of three distinct concentrations; 1, 4 and 6 μg/band (for GUF), 0.5, 2, and 3 μg/band (for BR and SAL), 0.2, 0.8, and 1.4 μg/band (for GUL) for TLC-densitometeric method. For HPLC method, concentrations applied were; 3, 15 and 30 μg/ mL for all components
^bLOD = (SD of the intercept /slope) × 3.3
^cLOQ = (SD of the intercept /slope) × 10

ISSN: 2661-801X