A VALIDATED RP-HPLC METHOD FOR THE DETERMINATION OF DESIDUSTAT IN PHARMACEUTICAL DOSAGE FORM

A VALIDATED RP-HPLC METHOD FOR THE DETERMINATION OF DESIDUSTAT IN PHARMACEUTICAL DOSAGE FORM
Author(s):
Dr. S. Naazneen
Keywords:
Acetonitrile, Anemia, Desidustat, Oxemia, RP-HPLC, Water.
Abstract
An accurate, sensitive, precise, fast isocratic reverse phase HPLC (RP-HPLC) method has been developed and validated for the quantification of Desidustat in bulk and pharmaceutical tablet dosage forms. With acetonitrile as the organic solvent, the best separation was achieved on a 250 mmx 4.6 mm i.d., 5µ-particle size Inertsil®-Octadecyl-silyl-3V-Reverse-Phase-C18-column with 0.03M Potassium Dihydrogen Orthophasphate in water pH: 3.2 with Orthophosphoric acid: Acetonitrile (55:45) as the mobile phase solvent in the isocratic mode of elution at a speed of 0.8 ml.min−1. UV detection was at 246 nm. Retention time of Desidustat was 4.67 minutes. With a correlation coefficient of about 0.999, peak-response was obtained as a function of concentration over the range of 40 to 120 µg/ ml for Desidustat. Desidustat was shown to have a percentage assay of 98.6%. Desidustat had a limit of detection of 0.05 mcg/ ml and a limit of quantification (LOQ) of 0.15 mcg/ ml. The presence of excipients in the formulation had no effect on the assay method. The procedure is appropriate for use in QC- laboratories since it is economical and precise.
Article Details
Unique Paper ID: 161587 Publication Volume & Issue: Volume 10, Issue 5 Page(s): 142 - 147
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