Stability Indicating Method Development and Validation for Oflaxacin and Metronidazole in Bulk and Dosage Form using RP-HPLC

Sanju Srinivas¹, T. Mounika²
1Associate Professor Department of Pharmacy, Ganga Pharmacy College, Nizamabad, Telangana
2Department of Pharmaceutical Analysis, Ganga Pharmacy College, Nizamabad, Telangana

ABSTRACT
A new method was established for simultaneous estimation of Ofloxacin and Metronidazole by RP-HPLC  method. The chromatographic conditions  were  successfully  developed  for  the separation  of  Ofloxacin  and  Metronidazole  by  using  Agilent  C18  5µm  (4.6*250mm) column, flow rate was  1ml/min, mobile phase ratio  was  Methanol: ACN (70:30%v/v), detection wave length was 238nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, PDA Detector 996, Empower-software version-2.The retention times were   found   to   be   2.443  mins   and   2.918  mins.  The   % purity of  Ofloxacin   and Metronidazole was  found  to  be  100.7%  and 101.4%  respectively.  The  system  suitability parameters for Ofloxacin  and  Metronidazole such  as  theoretical  plates  and  tailing  factor were found to be 1.7, 2114.5 and 1.7, 2931.0 the resolution was found to be 8.0. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study for Ofloxacin and Metronidazole was found in concentration range  of  1μg-5μg and 100μg-500μg and correlation coefficient (r2) was found to be 0.999 and 0.999, % mean recovery was found to be 100% and 100.5%, %RSD for repeatability was 2.0 and 2.0, % RSD for intermediate precision was 1.5 and 1.1 respectively. The precision study was  precise, robust, repeatable, LOD value was 2.95, 3.04 and LOQ value was 9.87 and 10 respectively.
Keywords: Agilent C18, Ofloxacin and Metronidazole, RP-HPLC method