Abstract

Megha Patel*, Vishal Chudasama, Kiran Suthar, Bharat Rajpurohit and Ashok Patel

ABSTRACT

The purpose of the present research was to develop a suitable, simple, precise, accurate, robust and reproducible RP-HPLC method for reliable simultaneous estimation of Metronidazole and Norfloxacin a in bulk powder and pharmaceutical preparation (Suspensions). The samples were assayed by the Merck-Hitachi isocratic high performance liquid chromatography system comprising of Hitachi pump L- 7110, The chromatographic separations were performed using LiChrospher? 100 C18, 5 μm, 250 × 4.0 mm internal diameter column, at ambient temperature. The mobile phase comprised of phosphate buffer and acetonitrile in the proportion of 80:20 (v/v) with final pH adjusted to 5.35 ± 0.02 with o-phosphoric acid, and was pumped at a flow rate of 1.0 ml/min. The wavelength for detection was 300 nm. The Retention time of Metronidazole and Norfloxacin was 3.39 min and 5.35 min, respectively. The method was validated by determining system suitability, selectivity, sensitivity, linearity, inter-day and intra-day precision, accuracy, robustness in accordance with the ICH guidelines. The calibration curve was linear over the concentration range of 1-70 ?g/ml for both the drugs, with co-efficient of correlation, (r2) 0.9994 and 0.9993 for Metronidazole and Norfloxacin respectively. (n=6). Linearity of Metronidazole and Norfloxacin was in the range of 1-70 μg/ml for both the drug. Average percentage recoveries obtained for Metronidazole and Norfloxacin were 99.78% and 100.06 %, respectively. The limit of detection and limit of quantification were found to be 0.5 and 1 μg/ml for Metronidazole, respectively and for Norfloxacin were 0.35 and 1 μg/ml, respectively. The developed chromatographic method proved to be simple, precise, accurate, robust, and reproducible. Thus, it can be used for the routine simultaneous estimation of Metronidazole and Norfloxacin in bulk powder as well as marketed pharmaceutical preparation.