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Development of a New UPLC Method for Simultaneous Determination of Valsartan, Amlodipine Besylate, and Hydrochlorothiazide Pharmaceutical Products

Lahsini R., Monser L.

Acta Chromatographica

2015

Vol. 27, no. 3

449--460

A new ultra-performance liquid chromatography method for the simultaneous determination of valsartan, amlodipine besylate, and hydrochlorothiazide in pharmaceutical formulations has been developed. Chromatographic separation was achieved within 1 min on a sub-2 μm RP18 column using an isocratic mode mobile phase consisting of a mixture of methanol and phosphate buffer (0.05 M, pH 3 ± 0.05) in the ratio 70:30 (v/v). The flow rate was set at 0.3 mL min-1 with a detection wavelength of 239 nm. The method was validated over the concentration ranges from 6.5 to 15.0 μg Ml -1 for hydrochlorothiazide, from 5.0 to 12 μg Ml-1 for amlodipine besylate and from 76.5 to 178.5 μg Ml-1 for valsartan. Calibration plots were linear for valsartan, amlodipine besylate, and hydrochlorothiazide with a correlation coefficient greater than 0.99. Relative variation coefficients for repeatability and reproducibility were less than 3.0%. Recoveries from standard addition essay of individual component in pharmaceutical formulations were varied from 97.0% to 102.0%. The proposed method was successfully applied for the determination of valsartan, amlodipine besylate, and hydrochlorothiazide in pharmaceutical formulations with recoveries with respect to label amount in pharmaceutical formulations that varied from 98.0% to 102.9%. The low flow rate, short analysis time, and simple mobile phase composition make the method cost effective, rapid, nontedious, and successfully employed for simultaneous determination of these drugs in commercial pharmaceutical products.

Validated RP-HPLC method for the simultaneous determination of amlodipine besylate, valsartan, and hydrochlorothiazide in bulk and in pharmaceutical formulation

Anandakumar K, Jothieswari D, Subathrai R, Santhi D. V, Vetrichelvan T

Acta Chromatographica

2012

Vol. 24, no. 1

37--50

A reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed for the simultaneous estimation of amlodipine besylate (AMB), valsartan (VAL), and hydrochlorothiazide (HCT) in pharmaceutical formulation using RP-C18 column. The mobile phase (acetonitrile:methanol:50 mM phosphate buffer adjusted to pH 3 with orthophosphoric acid) was pumped at a flow rate of 1.0 mL min-1 in the ratio of 20:50:30% v/v and the eluents were monitored at 239 nm. Linearity was obtained in the concentration range of 0.5–5 μg mL-1 for AMB, 4–40 μg mL-1 for VAL, and 1–10 μg mL-1 for HCT. The method was validated as per International Conference on Harmonization (ICH) guidelines and statistically. The method was validated for accuracy and precision. For precision, the coefficient of variance (COV) was found to be 0.3794, 0.1703 and 0.0578, and for accuracy, it was found to be 0.6351, 0.7688 and 1.1305 for AMB, VAL, and HCT, respectively. The COV values for all the drugs were found to be less than 2%, indicating high degree of precision and accuracy of the proposed high-performance liquid chromatographic (HPLC) method. Owing to its simplicity, rapidness, high precision and accuracy, the proposed HPLC method can be applied for determining AMB, VAL, and HCT in bulk and in pharmaceutical dosage form.