ABSTRACT

The combination of ofloxacin, ornidazole and racecadotril (Antof-OR) is used for the treatment of diarrhea. Due to the lack of a defined analytical approach upto this point, a rapid, accurate, repeatable, and easy HPLC method was developed to qualify and quantify these three APIs in mixed dose forms. In this study, the RP-HPLC method was used to quantify and qualify the marked dosage forms and to determine the stability of ofloxacin, ornidazole, and racecadotril in suspension dose form, along with the determination and quantification of different degradants. C18 column using ACN: MeOH: H2 O (40:40:20 V/V/V) as mobile phase was studied. The flow was carried out at 1 mL min-1 to get a proper resolution between the peaks and UV was used as detector at 210 nm (isosbestic point). Retention times of ofloxacin, ornidazole, and racecadotril were 2.215, 3.113, and 4.650 minutes, respectively. The ICH Q2R1 guidelines for specificity, linearity, precision, accuracy, and robustness, Further, the force degradation study was carried out as per ICH Q1A and Q1B. The procedure exhibits high repeatability and recovery as % RSD was less than 2. As a result, the proposed strategy was determined to be straightforward, specified, accurate and linear. This newly developed and validated analytical method shall be helpful in the regular quantification of ofloxacin, ornidazole, racecadotril in pharmaceutical suspensions.