ISSN: 2249–9504
CAS CODEN: IJPCDX

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF DROPERIDOL AND FENTANYL CITRATE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP- HPLC

Abstract

Author(s): Sumalatha Nallagundla*, Nallagundla HS Reddy, Ashwini B, Tejaswini R, Aparna D, Sirisha T and Kushal V

The purpose of the study is to develop and validate a simple, accurate, precise and rapid isocratic reverse-phase high-performance liquid chromatographic method for simultaneous determination of Droperidol and Fentanyl citrate in bulk and tablet formulations. Chromatographic separation was supported on Agilent C18 5µm column with a blend of phosphate buffer pH 4.0: ACN (30:70%v/v) as mobile phase at a flow rate of 1 ml/min. UV detection was performed at 254 nm using HPLC Alliance Waters® separation module 2695 with Empowersoftware. The retention times were found to be 3.503 mins and 2.577 mins for droperidol and fentanyl citrate, respectively. Calibration plots were linear (r2 =0.999) over the concentration range 20-100 μg/ml for Droperidol and Fentanyl citrate. Theoretical plates and tailing factor for Droperidol and Fentanyl citrate were found to be 1.3, 5824.4 and 1.2, 2936.0 respectively and the resolution was found to be 9.4. The optimized method was validated in accordance with ICH guidelines(IC(R1)) for accuracy, precision, specificity, linearity, and sensitivity. The proposed method was successfully used for quantitative analysis of tablets. No interference from any component of pharmaceutical dosage form was observed. Validation studies revealed that method is specific, rapid, reliable, and reproducible. As the method shows high recovery and low relative standard deviation which confirms the suitability of the method for routine determination of Droperidol and Fentanyl citrate in bulk drug and tablet dosage forms.

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