Method development and validation for the simultaneous estimation of ambroxol Hcl and loratadine in a pharmaceutical formulation by RP-HPLC method
Journal Title: International Journal of Pharmacy and Analytical Research - Year 2014, Vol 3, Issue 4
Abstract
An isocratic Simultaneous estimation by RP-HPLC Method were developed and validated for the quantification of Ambroxol HCl and Loratadine in tablet dosage form. Quantification was achieved by using a reversed-phase C18 column (INERTSIL Column , 5µ, 250 mm × 4.6 mm) at ambient temperature with mobile phase consisting of Phosphate Buffer buffer (30mM) pH: 4.5: Acetonitrile : Methanol (30: 50:20). The flow rate was 1.0 ml/min. Measurements were made at a wavelength of 220nm. The average retention time for Ambroxol HCl and Loratadine were found to be 2.450 min and 4.367. The proposed method was validated for selectivity, precision, linearity and accuracy. The assay methods were found to be linear from 72-168 µg/ml for Ambroxol HCl and 6 to 14 µg/ml for Loratadine. All validation parameters were within the acceptable range. The developed method was successfully applied to estimate the amount of Ambroxol HCl and Loratadine in tablet dosage form.
Authors and Affiliations
Dondeti mogli reddy
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- EP ID EP656708
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