Analytical Method Development and Validation for Haloperidol and Seroquel Combine Pharmaceutical Dosage Forms by RP-HPLC

T.Anusha¹, D. Naresh², Gampa Vijay Kumar*^3
1KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
²KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
³Professor and Head, Dept. of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.

ABSTRACT
The proposed HPLC method was found to be simple, specific, precise, accurate, rapid and economical for simultaneous estimation of Haloperidol Acetaminophene and Seroquel in tablet dosage form. The developed method was validated in terms of accuracy, precision, linearity, robustness and ruggedness, and results will be validated statistically according to ICH guidelines. The Sample recoveries in all formulations were in good agreement with their respective label claims. From literature review and solubility analysis initial chromatographic conditions. Agilent column (4.6×150mm)5µ, flow rate was 1.0ml/min, mobile phase ratio was (70:30 v/v) ACN: phosphate buffer(KH₂PO₄and K₂HPO₄) phosphate pH 3 ( pH was adjusted with orthophosphoric acid),detection wavelength was 230 nm. The retention times were found to be 2.462 & 3.737 mins. The % purity of Haloperidol and Seroquel was found to be 99.87% and 100.27% respectively. The system suitability parameters for Haloperidol and Seroquel such as theoretical plates and tailing factor were found to be 2733, 1.6 and 3500 and 1.4, the resolution was found to be 4.6. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Haloperidol and Seroquel was found in concentration range of 8µg-40µg and 20µg-100µg and correlation coefficient (r²) was found to be 0.999 and 0.999, % recovery was found to be 100.1% and 103.1%, %RSD for repeatability was 1.15 and 0.21, % RSD for intermediate precision was 0.3 and 0.18 respectively. The precision study was precision, robustness and repeatabilty.LOD value was 0.574 and 0.34 and LOQ value was 1.7 and 1.04 respectively.
Keywords: HPLC, Haloperidol, Seroquel, ACN: phosphate buffer, Agilent C 18.