Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ALBENDAZOLE IN BULK, TABLET, AND ITS ORAL SUSPENSION DOSAGE FORM

Pankaj Chander, Ashu Rathi, *Himanshu, Rajiv Kumar Tonk and Robin Kumar

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Abstract

Aim: A method for the simultaneous estimation of albendazole in bulk, tablets, and oral suspension dosage form is developed and validated using reversed phase high performance liquidchromatography (RP-HPLC). Objective: This attempt is made because there isn't a single RP-HPLC method that can simultaneously estimate albendazole in bulk, tablet, and oral suspension dosage form. Materials and Methods: The chromatography was performed using an instrument Thermo Scientific Fischer model number Dionex Ultimate 3000, with column ODS Nucleodur C18, having dimension 250 mm × 4.6 mm i.d, 5μm particle size, mobile phase OPA (0.1%) in water: Acetonitrile 60:40 (v/v) with a flow rate of 1.0ml/min. The injection volume was fixed at 10 μl. The detection was done using PDA detector at a λmax. of 308 nm. The diluent used for making dilutions was 1% (v/v) solution of sulphuric acid in Methanol: Water in 50:50(v/v) ratio. The method was validated in accordance with ICH guidelines by studying the parameters like specificity, linearity, accuracy, precision, robustness, system precision. Result: The albendazole was eluted with the retention time of about 3.90 minute. The linearity was achieved in the concentration ranges 50 μg/ml – 150μg/ml and the observed regression coefficient (R2) value was found as 0.9941 for this linearity. The percentage recovery for albendazole was found in between 99.19% to 100.01 for bulk, 99.17% to 99.83% for Tablet, 99.54% to 100.80% for oral suspention. Conclusion: The method's suitability for the simultaneous determination of albendazole in bulk, tablet, and oral suspension dosage form is confirmed by the high recovery values.

Keywords: Albendazole, RP-HPLC, Oral Suspension, Method Development, Validation, Nucleodur.