Published:Journal of Chromatographic Science,
ISSN 0021-9665 Volume
48, Number 1, January 2010, pp. 45-48
Stability-Indicating HPTLC Determination of Ambroxol
Hydrochloride in Bulk Drug and Pharmaceutical Dosage Form
P.S. Jain
R.C. Patel College of Pharmacy, Karwand Naka, Shirpur Dist. Dhule
425 405 (M.S.) India
A simple, selective, precise, and stability-indicating
high-performance thin-layer chromatographic (HPTLC) method for
the analysis of ambroxol hydrochloride both as a bulk drug and
in formulations was developed and validated. The method employed
HPTLC aluminium plates precoated with silica gel 60F-254 as the
stationary phase. The solvent system consisted of methanol–triethylamine
(4:6 v/v). The system was found to give a compact spot for ambroxol
hydrochloride (Rf value of 0.53 ± 0.02). Densitometric
analysis of ambroxol hydrochloride was carried out in the absorbance
mode at 254 nm. The linear regression analysis data for the calibration
plots showed good linear relationship with r2 = 0.9966 ± 0.0013
with respect to peak area in the concentration range 100–1000
ng/spot. The mean value ± standard deviation of slope
and intercept were 164.85 ± 0.72 and 1168.3 ± 8.26
with respect to peak area. The method was validated for precision,
recovery, and robustness. The limits of detection and quantitation
were 10 and 30 ng/spot, respectively. Ambroxol hydrochloride
was subjected to oxidation and thermal degradation. The drug
undergoes degradation under oxidation and heat conditions. This
indicates that the drug is susceptible to oxidation and heat.
Statistical analysis proves that the method is repeatable, selective,
and accurate for the estimation of said drug. Stability indicating
of new chemical entities is an important part for the drug development
of ambroxol hydrochloride and for its estimation in plasma and
other biological fluids; the novel Statistical analysis proves
that the method is repeatable and selective for the analysis
of ambroxol hydrochloride as bulk drug and in pharmaceutical
formulations. The proposed developed HPTLC method can be applied
for identification and quantitative determination of ambroxol
hydrochloride in bulk drug and dosage forms. This work is to
determine the purity of the drug available from the various sources
by detecting the related impurities.
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