RP-HPLC Estimation of Clobetasol Propionate and Salicylic Acid using Quality by Design Approach

Kunal S. Bagad¹, Kunal Bacchao¹, Shashikant B. Bagade², Rakesh D. Amrutkar³ and Dipak D. Patil^3*

¹Pharmaceutical Quality Assurance Department, H. R. Patel Institute of Pharmaceutical Education and Research, Shirpur. Dist. Dhule. Maharashtra, India.

²Pharmaceutical Chemistry, SVKM's NMIMS, School of Pharmacy and Technology Management, Mumbai-Agra Highway No. 3, Sawalde, Babulde, Post. Gidhade,Tq.-Shirpur. Dist- Dhule, Maharashtra India.

³Pharmaceutical Chemistry Department, K. K. Wagh College of Pharmacy, Nashik. Hirabai Haridas Vidyanagari, Amrutdham, Panchavati, Nashik. Maharashtra, India.

Corresponding Author E-mail: dipakpatil888@gmail.com

DOI : http://dx.doi.org/10.13005/bbra/3225

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.

KEYWORDS: Clobetasol propionate, Ointment analysis, RP-HPLC Salicylic acid

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