Determination of nebivolol hydrochloride and hydrochlorothiazide in tablets by first-order derivative spectrophotometry and liquid chromatography.
Two simple and accurate methods for analysis of nebivolol hydrochloride (NEB) and hydrochlorothiazide (HCTZ) in their combined dosage forms were developed using first-order derivative spectrophotometry and reversed-phase liquid chromatography (LC). NEB and HCTZ in their combined dosage forms (tablets) were quantified using first-derivative responses at 294.6 and 334.6 nm in the spectra of their solutions in methanol. The calibration curves were linear in the concentration range of 8-40 microg/mL for NEB and 10-60 microg/mL for HCTZ. LC analysis was performed on a Phenomenex Gemini C18 column (250 x 4.6 mm id, 5 microm particle size) in the isocratic mode with 0.05 M potassium dihydrogen phosphate-acetonitrile-methanol (30 + 20 + 50, v/v/v; pH 4) mobile phase at a flow rate of 1 mL/min. Detection was made at 220 nm. Both of the drugs and the internal standard (ezetimibe) were well resolved with retention times of 5.1 min for NEB, 2.9 min for HCTZ, and 8.2 min for ezetimibe. The calibration curves were linear in the concentration range of 1-14 microg/mL for NEB and 0.3-28 microg/mL for HCTZ. Both methods were validated and found to be accurate, precise, and specific, and results were compared statistically. Developed methods were successfully applied for the estimation of NEB and HCTZ in their combined dosage forms.
Shah
Dimal A
DA
Anand Pharmacy College, Opposite Town Hall, Shri. Ramkrishna Seva Mandal Campus, Anand, Gujarat, India. dimalgroup@yahoo.com
Bhatt
Kashyap K
KK
Mehta
Rajendra S
RS
Baldania
Sunil L
SL
D000959:Antihypertensive Agents / Q000032:analysis*; D001578:Benzopyrans / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D004983:Ethanolamines / Q000032:analysis*; D006852:Hydrochlorothiazide / Q000032:analysis*; D007202:Indicators and Reagents; D000068577:Nebivolol; D012015:Reference Standards; D015203:Reproducibility of Results; D012996:Solutions; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets
D000959:Antihypertensive Agents; D001578:Benzopyrans; D004983:Ethanolamines; D007202:Indicators and Reagents; D012996:Solutions; D013607:Tablets; D000068577:Nebivolol; D006852:Hydrochlorothiazide