Validated specific HPLC methods for determination of prazosin, terazosin and doxazosin in the presence of degradation products formed under ICH-recommended stress conditions.
The present paper describes development of stability-indicating high-performance liquid chromatographic (HPLC) assay methods for three alpha-adrenergic-blocker drug substances, namely, prazosin, terazosin and doxazosin, in the presence of degradation products generated from forced decomposition studies. Resolution of drugs from degradation products was obtained using a reversed-phase C-18 column using water/acetonitrile/methanol/glacial acetic acid/diethylamine (25:35:40:1:0.017) as mobile phase for prazosin and terazosin and acetonitrile/water/glacial acetic acid/diethylamine (65:35:1:0.02) for doxazosin. The detection was done at 254 nm. The methods were validated with respect to linearity, precision, accuracy, specificity and robustness.
Bakshi
Monika
M
Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research, Sector 67, S.A.S. Nagar Punjab 160 062, India.
Ojha
Tina
T
Singh
Saranjit
S
D002851:Chromatography, High Pressure Liquid / Q000379:methods; D017292:Doxazosin / Q000032:analysis* / Q000737:chemistry; D011224:Prazosin / Q000031:analogs & derivatives* / Q000032:analysis* / Q000737:chemistry; D015203:Reproducibility of Results; D013314:Stress, Mechanical
C041226:Terazosin; D017292:Doxazosin; D011224:Prazosin