title: Development and validation of a high-performance liquid chromatographic method for determination of eprosartan in bulk drug and tablets.
abstract: A simple, precise, and accurate isocratic RP-HPLC method was developed and validated for determination of eprosartan in bulk drug and tablets. Isocratic RP-HPLC separation was achieved on a Phenomenex C18 column (250 x 4.6 mm id, 5 microm particle size) using the mobile phase 0.5% formic acid-methanol-acetonitrile (80 + 25 + 20, v/v/v, pH 2.80) at a flow rate of 1.0 mL/min. The retention time of eprosartan was 7.64 +/- 0.05 min. The detection was performed at 232 nm. The method was validated for linearity, precision, accuracy, robustness, solution stability, and specificity. The method was linear in the concentration range of 10-400 microg/mL with a correlation coefficient of 0.9999. The repeatability for six samples was 0.253% RSD; the intraday and interday precision were 0.21-0.57 and 0.33-0.71% RSD, respectively. The accuracy (recovery) was found to be in the range of 99.86-100.92%. The drug was subjected to the stress conditions hydrolysis, oxidation, photolysis, and heat. Degradation products produced as a result of the stress conditions did not interfere with detection of eprosartan; therefore, the proposed method can be considered stability-indicating.
authors.affiliation: Shri Sarvajanik Pharmacy College, Department of Pharmaceutical Chemistry, Mehsana-384001, India. harshaupatel@yahoo.co.in
authors.forename: Harsha U
authors.initials: HU
authors.lastname: Patel
authors.forename: Bhanubhai N
authors.initials: BN
authors.lastname: Suhagia
authors.forename: Chhaganbhai N
authors.initials: CN
authors.lastname: Patel
mesh_terms: D000179:Acrylates / Q000032:analysis*; D047228:Angiotensin II Type 1 Receptor Blockers / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D007093:Imidazoles / Q000032:analysis*; D007202:Indicators and Reagents; D019999:Pharmaceutical Solutions; D012015:Reference Standards; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets; D013876:Thiophenes / Q000032:analysis*
chemical_list: D000179:Acrylates; D047228:Angiotensin II Type 1 Receptor Blockers; D007093:Imidazoles; D007202:Indicators and Reagents; D019999:Pharmaceutical Solutions; D013607:Tablets; D013876:Thiophenes; C068373:eprosartan