Development and validation of a high-performance liquid chromatographic method for the analysis of propylthiouracil in pharmaceuticals.
A simple, rapid, and stability-indicating high-performance liquid chromatographic (HPLC) method was developed and validated for the assay of propylthiouracil (PTU). The method was used to quantify PTU in topical formulations and in tablets. Excellent linearity was observed between PTU concentration and the peak area (R2= 0.999). The limit of detection was 1 ng, and the limit of quantitation was 1.2 ng. The method proved to be selective. Selectivity was validated by subjecting a stock solution of PTU to acidic, basic, and oxidative degradations. The peaks of the degradation products did not interfere with the peak of PTU. Excipients present in the dosage forms did not interfere with the analysis, and the recovery of PTU from each dosage form was quantitative.
Abdul-Fattah
A M
AM
Department of Pharmaceutical Sciences, Massachusetts College of Pharmacy and Health Sciences, Boston, MA 02115, USA.
Bhargava
H N
HN
D013956:Antithyroid Agents / Q000008:administration & dosage / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D007202:Indicators and Reagents; D009824:Ointments; D010084:Oxidation-Reduction; D011441:Propylthiouracil / Q000008:administration & dosage / Q000032:analysis*; D012015:Reference Standards; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets
D013956:Antithyroid Agents; D007202:Indicators and Reagents; D009824:Ointments; D013607:Tablets; D011441:Propylthiouracil