• Dr. S. Naazneen

An accurate, simple, sensitive, precise, fast isocratic reverse phase HPLC (RP-HPLC) method has been developed and validated for quantification of Nitisinone 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 ammonium acetate in water: acetonitrile (50:50 v/v) in the isocratic mode of elution as mobile phase solvent at a speed of 0.8 mL.min−1. UV detection was at 212 nm. Retention time of Nitisinone was 3.0 minutes. With a correlation coefficient of about 1.000, peak-response was obtained as function of concentration over the range of 40 to 120 µg/ mL for Nitisinone. Nitisinone was shown to have a percentage assay of 110.31 %. Nitisinone had a limit of detection of 0.1 mcg/ mL and a limit of quantification (LOQ) of 0.3 mcg/ ml. The presence of excipients in the formulation Orfadin had no effect on the assay method. The procedure is appropriate for use in QC- laboratories since it is economical and precise.

Nitisinone, Orfadin, RP-HPLC, Isocratic, Acetonitrile.

"DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF NITISINONE IN BULK AND TABLET DOSAGE FORM", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.10, Issue 11, page no.b719-b725, November-2023, Available :http://www.jetir.org/papers/JETIR2311187.pdf

"DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF NITISINONE IN BULK AND TABLET DOSAGE FORM", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.10, Issue 11, page no. ppb719-b725, November-2023, Available at : http://www.jetir.org/papers/JETIR2311187.pdf