STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF LEVAMISOLE HCl AND ALBENDAZOLE IN TABLET DOSAGE FORM
Purvi A. Patel*, Dr. Anuradha P. Prajapati, Dr. Shailesh V. Luhar, Dr. Sachin B. Narkhede
ABSTRACT
The purpose of the investigation was to develop a new RP-HPLC Method for simultaneous estimation of Albendazole and Levamisole HCl in pharmaceutical dosage forms. Chromatography was carried out on an Shiseido C18 column (4.6 x 250mm, 5μ particle size) with a isocratic mobile phase Phosphate buffer : Acetonitrile 30:70 (v/v) (adjusted to pH 5 with 10 M potassium hydroxide), at a flow rate of 1.0 mL/min and the detection was carried out using a UV detector at 217 nm. Validation parameters such as system suitability, linearity, precision, accuracy, specificity, limit of detection (LOD), limit of quantification (LOQ), Stability of sample & standard stock solutions, robustness and degradation studies were determined as reported in the International Conference on Harmonization guidelines. The retention times for Albendazole and Levamisole HCl were 3.177 min and 5.370min respectively. The percentage recoveries of Albendazole and Levamisole HCl were 100.60% and 98.40% respectively. The relative standard deviation for assay of tablets was found to be less than 2%. The Method was fast, accurate, precise and sensitive hence it can be employed for routine quality control of tablets containing both drugs in quality control laboratories and pharmaceutical industries.
Keywords: Albendazole, Levamisole HCl, RP-HPLC Method, Stability indicating Method, Validation.
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