Ambroxol and N-Acetyl Cysteine
New Analytical Methods & Validation
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Spectrometric methods are a large group of analytical methods that are based on atomic and molecular spectroscopy. Colorimetric assays generally consists of adding a reagent to the assay preparation or to the substance being tested, to produce a colour that is compared with that of a standard preparation that has been prepared simultaneously and contains approximate quantity of the reference standard. In general, in analysis the first step is to determine the nature of the sample that is complete qualitative information and then further proceed for quantitative information by accuracy, LOD, LO...
Spectrometric methods are a large group of analytical methods that are based on atomic and molecular spectroscopy. Colorimetric assays generally consists of adding a reagent to the assay preparation or to the substance being tested, to produce a colour that is compared with that of a standard preparation that has been prepared simultaneously and contains approximate quantity of the reference standard. In general, in analysis the first step is to determine the nature of the sample that is complete qualitative information and then further proceed for quantitative information by accuracy, LOD, LOQ etc. Method validation is the process to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Rapid, sensitive, specific and validated colorimetric methods have been developed for the quantitative estimation of Ambroxol HCl and N-Acetylcysteine in bulk and dosage form.The proposed method was validated as per ICH guidelines and applying the same for it's estimation in marketed formulations.
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