RP-HPLC METHOD VALIDATION AND DEVELOPMENT FOR THE ESTIMATION OF PRULIFLOXACIN IN PHARMACEUTICAL DOSAGE FORM

Mishra Shambhu Nath*, Dr. Omray Lavakesh, Mr. Soni Pushpendra

Radharaman Institute of Pharmaceutical Sciences, Bhopal, Madhya Pradesh, India

ABSTRACT

The current research study, a successful practice was done for “Validated HPLC method development for the estimation of Prulifloxacin in marketed formulation”. Analytical method validation of Prulifloxacin tablets was developed via material and method plan which is based on logical experimental procedure through literature survey associated with statistical tools. Major instrument which was used is UV spectrophotometer (make shimadzu) and HPLC system was Shimadzu LC-2010CHT with Chromalion software. The isocratic mobile phase consisted of mixture of phosphate buffer preparation and acetonitrile in the ratio of 150:850 ml v/v and with PH 7.4 by adding triethylamine. Chromatographic parameters was follow is Column Xterra C18 125Å (250mm x 4.6mm x 0.5µm), Flow rate 1 ml/min, Injection volume 20µl, Column oven temperature 35oC, Sampler temperature 2-8oC and Run time 10 minute. Assay of prulifloxacin tablets (Alpruli 600 mg) in three set occur average %age is 100.63, all value between 98-102%. Proposed method was found to be linear in the range of 20-100 μg/ml prulifloxacin with the correlation coefficient near to one respectively. The validation and the reliability of proposed method was assessed by recovery study. The recovery of added standards (80%, 100% 120%) 99.7 %, 100.7 % and 100.4 % for prulifloxacin respectively. found prulifloxacin is stable in low temperature between 2-8oC upto 48 Hours.

Keywords:

Ulifloxacin, RP-HPLC, Stress testing. Antimicrobial, Non-polar