Abstract
Simple, rapid and accurate high performance liquid chromatographic (HPLC) and spectrophotometric methods are described for determination of antihistaminic acrivastine in capsules. The first method (method A) is based on accurate, sensitive and stability indicating chromatographic separation method. Chromolith® Performance RP-18e column, a relatively new packing material consisting of monolithic rods of highly porous silica, was used as stationary phase applying isocratic binary mobile phase of ACN and 25mM NaH2PO4 pH 4.0 in the ratio of 22.5:77.5 at flow rate of 5.0mL/min and 40°C. A diode array detector was used at 254nm for detection. The elution time of acrivastine was found to be 2.080±0.032. The second and third methods (methods B and C) are based on the oxidation of acrivastine with excess N-bromosuccinimide (NBS) and determination of the unconsumed NBS with, metol–sulphanilic acid (λmax: 520nm) or amaranth dye (λmax: 530nm). The reacted oxidant corresponds to the drug content. Beer’s law is obeyed over the concentration range 1.563–50, 2.0–20 and 1.0–10μgmL−1 for methods A, B and C, respectively. The limits of detection and quantitation were 0.40, 0.292 and 0.113μgmL−1 and 0.782, 0.973 and 0.376μgmL−1 for methods A, B and C, respectively. The HPLC method was validated for system suitability, linearity, precision, limits of detection and quantitation, specificity, stability and robustness. Stability tests were done through exposure of the analyte solution for four different stress conditions and the results indicate no interference of degradants with HPLC-method. The proposed methods was favorably applied for determination of acrivastine in capsules formulation. Statistical comparison of the obtained results from the analysis of the studied drug to those of the reported method using t- and F-tests showed no significant difference between them.
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