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100 _aPrince Singh Rajput
245 _aSIMULTANEOUS ANALYSIS OF OFLOXACIN, RACECADOTRIL AND ORNIDAZOLE IN PHARMACEUTICAL DOSAGE FORM BY RP-HPLC
300 _aP.47-54
520 _aThe 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.
654 _aICH guidelines
_aornidazole
_aracecadotril
_aofloxacin
_aRP-HPLC
_aforce degradation
700 _aSharib Raza Khan
773 0 _0125265
_9111176
_dMumbai Indian Drugs Manufacturer's Association
_oJP489
_tIndian Drugs
_x0019-462X
942 _cJA
942 _2ddc
999 _c130761
_d130761