Burla Sunitha Venkata Seshamamba, Peruri Veera Venkata Satyanarayana, Chandra Bala Sekaran*
Abstract
Background:
A simple, sensitive, selective and
precise stability indicating HPLC method is developed and validated for the
assay of ambrisentan in pharmaceutical dosage form.
Methods:
Separation of the drug was achieved on Agilent
Zorbax C18 column (250 mm × 4.6 mm I.D., 5 μm particle size) under the isocratic mode of elution. The solvent
system consisted of 0.1M potassium
dihydrogen phosphate buffer (pH was adjusted to 4.4 with orthophosphoric
acid) and methanol (30:70 v/v) at a flow rate of 1.0 ml/min. The method was carried out in the absorbance mode
at 210 nm. The method was statistically validated according to International
Conference on Harmonization guideline. Ambrisentan
was subjected to stress degradation studies under acidic, basic, oxidative,
thermal and photolytic conditions.
Results:
The system was found to
give compact peak for ambrisentan (Retention time is 3.315 min). The method was linear in the range of 1 - 150
µg/ml. The linear regression data for the calibration plot showed good
relationship (r2 =
0.9996). The relative standard
deviation and mean recovery values at different concentration levels were
within limits. The performance of the method was not changed when small
variations in the experimental conditions were made. Degradation
products resulting from stress degradation studies did not interfere with the
detection of ambrisentan.
Conclusion:
The
proposed stability indicting HPLC method is simple, precise, accurate, robust and selective. This
method can be used for quantification of ambrisentan in bulk drug and in
pharmaceutical dosage forms.