Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Satranidazole from Its Formulation

Satranidazole is a new nitroimidazole derivative with potent antiamoebic action and is available in market in the form of tablet and dry syrup either alone or in combination with Ofloxacin. The present study involves the development of simple, accurate, precise, and reproducible reversed phase high performance liquid chromatography (RP-HPLC) method for determination of Satranidazole from its granular dosage form. Isocratic elution at a flow rate of 1.0？mL/min was employed on BDS Hypersil C18 (250？mm × 4.6？mm, 5？μm) column at 25°C temperature. The mobile phase consists of 0.16%？v/v orthophosphoric acid solution, pH 3: acetonitrile in the ratio of 60？:？40？v/v. The UV detection wavelength was 320？nm, and 20？μL sample was injected. The retention time for Satranidazole was about 4.3 minutes. The method was validated for various parameters such as system suitability, precision, recovery, robustness, and ruggedness as per ICH guidelines. The validated RP-HPLC method was found to be specific, linear, precise, and accurate and can be successfully employed for the assay of Satranidazole taste masked granules coated with Eudragit E100 and marketed tablets. 1. Introduction Satranidazole (STZ) is a new nitroimidazole derivative with potent antiamoebic action. It is used in the treatment of intestinal and hepatic amoebiasis, giardiasis, trichomoniasis, and anaerobic infections. Its dose is 300？mg twice daily for 3–5 days in the treatment of amoebiasis and 600？mg as a single dose in the treatment of giardiasis and trichomoniasis. It is reported that Satranidazole exhibits significantly higher plasma concentrations than metronidazole and has a plasma elimination half-life of 1.01 hour which is significantly shorter than the corresponding metronidazole half-life of 3.62 hour [1]. Also Satranidazole is having better tolerability, absence of neurological, and disulfiram like reactions and it can be preferred in patients with susceptible neurological symptoms [2]. The structure of STZ is as shown in Figure 1. Literature survey revealed that there are various methods for individual determination of STZ by using RP-HPLC [3], HPLC [4], HPTLC [5, 6], and spectrophotometer [7] and also simultaneous estimation of STZ and Ofloxacin in tablet dosage form [8, 9]. Satranidazole is not official in any pharmacopoeia and no stability indicating method is reported for determination of Satranidazole in tablets and granular formulations. Hence, the present work was undertaken. Figure 1: Structure of Satranidazole. The objective of present study was to develop and validate an accurate,