A simple, rapid, sensitive, robust, RP-HPLC analytical method was developed and validated for the analysis of urapidil in bulk and in pharmaceutical formulation. The development of proposed method was achieved on a LC - GC Qualisil BDS C18 column (250 mm-4.6 mm, 5 Ã?µm) by gradient mode at ambient temperature, employing a mobile phase as Methanol: Water (70:30 v/v) pH of the aqueous mobile phase was adjusted to 5.8Ã?± 0.02 with ortho-phosophoric acid at a flow rate of 1.0 ml/min and detection at 268 nm. Design of experiments employing ââ?¬Ë?Central Composite Designââ?¬â?¢ (CCD) and ââ?¬Ë?Response Surface Methodologyââ?¬â?¢ (RSM) were applied as advancement to traditional ââ?¬Ë?One Variable at Timeââ?¬â?¢ (OVAT) approach to evaluate the effects of variations in selected factors (methanol content, flow rate) as graphical interpretation for robustness and statistical interpretation was achieved with linear regression and ANOVA. The method succeeded over the validation parameters viz linearity, precision, accuracy, limit of detection and limit of quantitation and robustness. The method was applied efficiently for analysis of urapidil.
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