Development and Validation of HPLC analytical methods used for determination of assay, content uniformity and dissolution of immediate release candesartan cilexetil 32 mg tablets
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Date
2017
Journal Title
Journal ISSN
Volume Title
Publisher
Polish Pharmaceutical Society
Access Rights
info:eu-repo/semantics/closedAccess
Abstract
New analytical methods have been developed and validated on high performance liquid chromatography (HPLC) to assess the assay, content uniformity and dissolution of immediate release candesartan cilexetil 32 mg tablets. Method development studies were performed on cyano column. Mobile phase of assay and content uniformity test consisted of mixture of 0.05 M phosphate buffer, pH 4.5 and methanol (40:60, v/v) adjusted to pH 4.0 with trifluoroacetic acid, whereas mobile phase of dissolution test consisted of mixture of 1 mM phosphate buffer and acetonitrile (50:50, v/v) adjusted to pH 2.0 with trifluoroacetic acid. Mobile phases were pumped at flow rate of 1.0 mL/min, ultraviolet-visible (UV) detector was operated at 254 nm, injection volume was set at 20 ?L, column temperature was held at 258C. Dissolution medium was 0.05 M phosphate buffer, pH 6.5 including 0.70% (w/v) polysorbate 20. Validation studies met acceptance criteria of system suitability, specificity, linearity and range, accuracy, precision, detection limit (LOD), quantitation limit (LOQ) and robustness parameters.
Description
Keywords
Assay; Candesartan Cilexetil; Content Uniformity; Dissolution; Method Validation; Tablet, Candesartan Hexetil; Carboxymethylcellulose; Hydroxypropylcellulose; Lactose; Macrogol 4000; Magnesium Stearate; Starch; Analytic Method; Article; Controlled Study; Drug Determination; Drug Release; Drug Solubility; High Performance Liquid Chromatography; Limit Of Detection; Limit Of Quantitation; Measurement Accuracy; Sensitivity And Specificity; Validation Study
Journal or Series
Acta Poloniae Pharmaceutica - Drug Research
WoS Q Value
Scopus Q Value
Q3
Volume
74
Issue
2
