Abstract

“DEVELOPMENT AND VALIDATION OF SPECTROSCOPIC METHOD FOR THE ESTIMATION OF METRONIDAZOLE AND NORFLOXACIN IN SYRUP DOSAGE FORM.”

JelamVazir*, Minal Rohit and Dr. Dhananjay Meshram

ABSTRACT

The main objective of present work is to develop simple, economic and reliable UV spectroscopic method for the routine analysis of Metronidazole and Norfloxacin in Syrup dosage form. There is no Literature found for estimation of Metronidazole and Norfloxacin in combined syrup dosage form by simultaneous UV spectroscopic method. So, Spectroscopic method was developed for simultaneous estimation of Metronidazole and Norfloxacin in syrup formulation by optimizing Acetic acid as a solvent for extraction. The developed method was validated as per ICH guidelines. The linearity range was found from 2-10μg/ml for both the drugs. Regression line equations were obtained Y=0.0892x+0.084 and Y=0.1839x+0.0377 for Metronidazole and Norfloxacin respectively. R2 values were obtained 0.995 and 0.996 respectively for Metronidazole and Norfloxacin. Repeatability, Intraday and inter day precision were carried out which gave %RSD<2. Accuracy was performed by spiking method. %RSD was obtained <2. Limit of detection for Metronidazole and Norfloxacin was obtained 0.068μg/ml and 0.014μg/ml respectively. Limit of quantification was obtained for Metronidazole and Norfloxacin was 0.229μg/ml and 0.047μg/ml respectively. From the results obtained from validation parameters we can conclude that developed method was linear, accurate and precise, so we can use this method for routine analysis of Metronidazole and Norfloxacin in syrup formulation.

Keywords: Analytical Method development, Validation, Metronidazole, Norfloxacin, Simultaneous Estimation Method.