Validated RP-HPLC method for determining the levels of bromhexine HCl, chlorpheniramine maleate, dextromethorphan HBr and guaiphenesin in their pharmaceutical dosage forms

Peer review under responsibility of Taibah University.

Figures & data

Fig. 1 Chemical structure of interacting compounds of (a) bromhexine hydrochloride (b) chlorpheniramine maleate (c) dextromethorphan hydrobromide (d) guaiphenesin.

Table 1 Data for the evaluation of the system suitability.

Property	BROM	CHL	DEX	GUA
R^t	16.254	12.219	6.156	9.432
Tf	1.09	1.04	1.13	1.29
K′	1.562	1.217	1.764	4.571
N	6359	1276	4925	18,743
Rs	3.98	2.72	0.00	3.15

R^t, retention time; T_f, tailing factor; K′, capacity factor; N, number of theoretical plates; R_s, resolution.

Table 3 Summary of validation parameters.

Parameter	BROM	CHL	DEX	GUA
Linearity range	4–24	5–30	10–60	10–60
Slope	9040	9579	25,935	34,255
Interept (y)	9993	−308	25,500	14,194
R^2	0.9987	0.9988	0.9981	0.9988
Accuracy (percentage of recovery)
80%	99.67	100.0521	101.2917	101.7354
100%	101.07	100.9583	101.225	101.185
120%	100.15	101.0417	100.9931	100.1035
Intraday precision
%COV	0.1755–0.6333	0.3050–0.6715	0.1806–0.6929	0.2813–0.8976
Interdays precision
%COV	0.1018–0.2804	0.0675–0.1639	0.1529–0.4252	0.1227–0.2925
L.O.D. (ng ml^−1)	21.49	29.17	11.65	8.1
L.O.Q. (ng ml^−1)	65.13	88.39	35.51	24.57
Specificity/selectivity	No interference
Robustness	Reliable results
Ruggedness	Reproducible results

Fig. 2 RP-HPLC chromatogram of placebo.

Table 2 Results from assay of the marketed formulation.

Drug	Label claim (mg/tab) n = 6	Amount found (mg/tab)	Label claim (%)	S.D.	S.E.	% COV
BROM	8	8.0365	100.45	0.5902	0.2410	0.5875
CHL	2	2.0052	100.25	1.2891	0.5263	1.2858
DEX	10	9.9887	99.88	0.7494	0.3059	0.7502
GUA	100	100.5601	100.56	0.7991	0.3262	0.7946

S.D, standard deviation; COV, coefficient of variance; S.E, standard error; n, number of replicates.

Fig. 3 HPLC-chromatogram of marketed formulation.