Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF FLURBIPROFEN SODIUM AND CHLORAMPHENICOL

Sanmesh Modi* and Dr. Ankit B. Chaudhary

ABSTRACT

“Review of Literature was done for both drugs, but there is no reported method for Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Flurbiprofen Sodium and Chloramphenicol. In RP-HPLC the quantification was carried out using Grace Smart C18 column (250 x 4.6mm, 5μm) and a mobile phase comprised of Buffer (Potassium Dihydrogen Phosphate pH 3.5): Acetonitrile (70:30v/v). The Flow rate was adjusted to 1 ml/min and the effluent was monitored at 239 NM using a PDA detector. The retention time (RT) 3.530 min and 6.463 min for Chloramphenicol and Flurbiprofen respectively. The method was validated in terms of linearity, precision, accuracy and specificity, limit detection and limit of quantization. The linearity for Chloramphenicol and Flurbiprofen were assessed by analysis of combined standard solution in range of 50-150μg/ml and 3-9 μg/ml respectively. The % RSD for Chloramphenicol and Flurbiprofen was found to be 0.178-0.481respectively for repeatability. The % RSD for Intraday precision was found to be 0.191-0.264 for Chloramphenicol and 0.253-1.280 for Flurbiprofen. The % R.S.D. for interday precision was found to be 0.278-0.329 for Chloramphenicol and 1.359-1.778 for Flurbiprofen. Percentage recovery for Chloramphenicol was 100.67-101.05 %, while for Flurbiprofen, it was found to be in range of 98.92-99.04%. The method was found to be precise, accurate and specific during the study. The proposed method enables rapid quantification and simultaneous analysis of both drugs from commercial formulations without any excipients interference. Forced degradation study of Chloramphenicol and Flurbiprofen sodium was performed by RP- HPLC method which includes Acid, Base, Oxidative, Thermal degradation and Photo stability. Results of degradation were found within limit.”

Keywords: Reverse Phase High Performance Liquid Chromatography Method, Infra-Red Spectroscopy Method, Stability Indicating Assay Method, Flurbiprofen sodium, Chloramphenicol.