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Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULATANEOUS ESTIMATION OF PYRANTEL PAMOATE AND ALBENDAZOLE IN BULK AND ITS TABLET DOSAGE FORM

Renuka Jajikore*, G. Ushasree, A. Ajitha, V. Umamaheswararao

The purpose of the investigation was to develop a new RP-HPLC Method for simultaneous estimation of Pyrantel pamoate and Albendazole in pharmaceutical dosage forms. Chromatography was carried out on an BDS C-18 column (4.6 x 250mm, 5μ particle size) with a isocratic mobile phase composed of 0.1% Potassium dihyrogen Ortho phosphate (adjusted to pH 4.8 with triethylamine solution), Acetonitrile, methanol (40:40:20v/v) at a flow rate of 1 mL/min. The column temperature was maintained at 30°C and the detection was carried out using a PDA detector at 311 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 Pyrantel pamoate and Albendazole and were 2.161 min and 3.405 min respectively. The percentage recoveries of Pyrantel pamoate and Albendazole were 99.29% and 99.40% 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.


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Citations : 938

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