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Context: Ambroxol Hcl is an active metabolite of bromohexine. It is an expectoration improver and a mucolytic agent used in the treatment of bronchial asthma and chronic bronchitis.The available formulation of Ambroxol was authorized first in market since 1978. Objective:This article highlights on published analytical methods reported in the litera...
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... et al. studied Ambroxol HCl in biological material by using gas chromatography with electron-capture detection. Pinazepam, was used as internal standard, at a concentration of 5 ng/ml in methanol. The % Recovery was found to be 100 ±2.3 % R .S.D. The limit of detection was 4 ng/ml of Ambroxol HCl for all the biological samples. One unknown impurity of Ambroxol was formed in the formulated drug under stress conditions (40°C /75% relative humidity (RH) for 6 months) with the relative retention time (RRT) 0.68 in RP-HPLC. The impurity was enriched by exposing it to heat and it was isolated by using preparative HPLC. The enriched impurity was purified and characterized using the following sophisticated techniques: 2D NMR (gDQ-COSY, gHSQC, and gHMBC), FTIR, and LC-MS/MS. On the basis of the spectral data, the impurity was characterized as trans-4-(6,8-dibromoquinazolin- 3(4H)-yl)cyclohexanol. ( Thummala.et al. 2014). The comparative sensitive methods of various techniques are shown in Figure. 4. ...
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A simple, step by step, cost-effective, accurate, sensitive, and selective validated High Performance Thin Layer Chromatographic method for simultaneous determination of Terbutaline sulphate, Ambroxol hydrochloride, and Guaifenesin in syrup formulation has been developed and validated. HPTLC separation was achieved on Merck aluminum HPTLC plates precoated with silica gel 60 F254. The solvent system comprised of Chloroform: Methanol: Ethyl acetate: Acetic acid: Formic acid (7.0:1.4: 0.8:1.0:0.5 v/v). Densitometric detection wavelength at 200 nm was used in reflectance-absorbance mode. The retention factors were found to be 0.32±0.02, 0.55± 0.02, and 0.72±0.02, for Terbutaline sulphate, Ambroxol hydrochloride, and Guaifenesin respectively. Results were found to be linear over a range of 200 - 700ng band-1, 1000 - 7000ng band-1, and 400-1200ng band-1 for Terbutaline sulphate, Ambroxol hydrochloride, and Guaifenesin, respectively. The percent assay was found to be 98.47%, 98.47%, and 99.23%, for Terbutaline sulphate, Ambroxol hydrochloride, and Guaifenesin, respectively in marketed formulation. The developed densitometric method was validated by following the International Council on Harmonisation (ICH) guideline. The developed and validated chromatographic method can be applied for routine quality control of Terbutaline sulphate, Ambroxol hydrochloride, and Guaifenesin in the combined syrup dosage form used in study.
