Development and Validation of UV Spectrometric and HPLC Method for Estimation of Escitalopram Oxalate and Flupentixol Dihydrochloride in Combined Dosage Form
Abstract
Shivani C. Patel*, Dilip G. Maheshwari*
Reverse phase High-performance liquid chromatographic (HPLC) and UV spectrophotometric methods were developed and validated for the quantitative determination of Escitalopram oxalate and Flupentixol dihydrochloride in combined dosage form. Different analytical performance parameters such as linearity, precision, accuracy, specificity, limit of detection (LOD) and limit of quantification (LOQ) were determined according to ICH Q2R1 guidelines. The RP-HPLC method was developed by the isocratic technique on a column of Kromasil C8 (250×4.6 mm, 5 μm). The retention time for ESC and Flu was 3.6 min and 5.8 min respectively. The UV spectrophotometric determinations were performed at the zero crossing point (ZCP) of ESP was found to be 238 nm and ZCP of Flu was found to be 229 nm. The linearity of the calibration curves for each analyte in the desired concentration range was good (r2 > 0.999) by both the HPLC and UV methods. The method showed good reproducibility and recovery with percent relative standard deviation less than 2%. Moreover, UV spectroscopy can be a cheap, reliable and less time consuming alternative for chromatographic analysis. The proposed methods are highly sensitive, precise and accurate and hence successfully applied for determining the assay of a Combined dosage form.
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