Abstract

DEVELOPMENT AND VALIDATION OF NEW ANALYTICAL METHOD FOR THE SIMULTANEOUS DETERMINATION OF FIVE DIFFERENT DRUG SUBSTANCE IN DRUG PRODUCT USING SUB TWO MICRON COLUMN.

Shivaji Jadhav* and Dr. Amit Gosar

Abstract

A novel selective and fast indicating High performance liquid chromatography method has been developed for the simultaneous assay of Paracetemol, Nimesulide, Aceclofenac, Diclofenac, Ibuprofen by using sub 2 micron column. In reverse phase chromatography efficient separation was achieved between all five compounds. This method was validated as per International Conference on Harmonization guidelines (Q2R1). The proposed RP-HPLC method utilizes a Reprosil Gold C18, 50 x 4.6 mm 1.8μ column and mobile phase consisting of Ammonium acetate buffer pH-3.5 with formic acid and Methanol using gradient program. UV detection at 220 nm for Ibuprofen, Paracetemol and 280nm for Nimesulide, Aceclofenac and Diclofenac Sodium was employed. The described method is accurate & linear in the given range. The observed mean recoveries were 99.91% to 100.53%.

Keywords: Paracetemol, Nimesulide, Aceclofenac, Diclofenac, Ibuprofen, Assay, Reverse phase and submicron column, Fast High performance liquid chromatography.