Method development and validation for the simultaneous estimation of ambroxol Hcl and loratadine in a pharmaceutical formulation by RPHPLC method
DOI:
https://doi.org/10.61096/ijpar.v3.iss4.2014.482-491Keywords:
Ambroxol HCl, Loratadine,, RP-HPLC method, INERTSIL Column, Methanol, Acetonitrile,, KH2PO4, Ortho phosphoric acid, ValidationAbstract
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.
