DEVELOPMENT AND VALIDATION FOR UV SPECTROMETRIC ESTIMATION OF AMBROXOL HYDROCHLORIDE IN BULK AND TABLET DOSAGE FORM USING AREA UNDER CURVE METHOD
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2014, Vol 5, Issue 7
Abstract
This paper describes development and validation of UV spectrophotometric method for the estimation of Ambroxol hydrochloride in bulk and pharmaceutical formulation using area under curve method. The standard and sample solutions of Ambroxol hydrochloride were prepared in methanol. The area under curve in between 238 to 258 nm was measured. The method followed linearity in the range of 2-12 μg/ml with correlation coefficient value of 0.999. This method was validated for various parameters according to ICH guideline Q2 (R1). Satisfactory values of Percent relative standard deviation for the intra-day and inter-day precision indicated that method was precise. The mean percentage recovery studies were found to be 100.69 %. Limit of Detection and Limit of Quantitation were calculated as 0.0841 μg/ml and 0.2551 μg/ml, respectively. Validation results suggest that the further developed method can be used for routine quality control analysis studies for Ambroxol hydrochloride in bulk and tablet dosage form.
Authors and Affiliations
Amol Ranjale , Hemant Jain , Kishore Gujar
Keywords
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- EP ID EP126797
- DOI 10.7897/2230-8407.0507118
- Views 89
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