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ABSTRACT: The RP-HPLC method for CLOP and SA estimation from bulk and pharmaceutical dosage from has been developed and validated. For analytical methods to be robust, current ICH guidelines, Q8 to Q11 were suggested use of analytical quality by design (AQbD) includes adoption of current systematic approaches. The proposed method was optimized and developed using Taguchi orthogonal design. The RP-HPLC method parameters were optimized by box- Behnken design. The stationary phase used C18 Princeton column (150mm × 4.6mm × 5µm) with acetonitrile: 0.05M phosphate buffer (pH 2.5, adjustment with by ortho - phosphoric acid) as mobile phase at ratio of 60:40v/v, 1.0 ml/min of flow rate along with UV-Visible wavelength of detection 240 nm. The linearity over concentration 5-15 µg/ml for CLOP and 600-1500 µg/ml for SA (r2 =0.9969 for CLOP and 0.9943 for SA) was found. The retention time for SA was 2.2 min. and CLOP 7.0 minute. The % recovery was found to be 98.0.3 SA and 97.84 or CLOP. As per ICH analytical method validation guidelines Q2 (R1), the RP-HPLC method was validated.
Bagad et al. (Sat,) studied this question.