ABSTRACT

According to USP method, a mixture of Potassium phosphate:acetonitrile (52:48) was used as mobile phase, the column having length of 4.6 mm × 25 cm and containing packing L7 which is maintained at 45 ± 1 ?C temperature. The injection volume was 10 ?l and the flow rate was 1.5 mL/min. In this method, the column used for experiment purpose, was packed with porous silica bonded to nitrile groups.C25 column contains stationary phase which is stable and it can tolerate pressure limit more than 6000 psi, for this reason mobile phase runs in uniform way and it provide uniform flow throughout the column. C25 column contains smaller particle size due to which plate increases resulting in higher efficiency. Octadecyl silane is used to increase the polarity of the stationary phase to give sharp and intense peak. In this work we have performed the assay of the tablet according to united state Pharmacopoeia, according to USP, the assay of Clonazepam Orally Disintegrating tablet was performed by HPLC, and then performed validation according to ICH guidelines. The method was validated for analytical parameters such as linearity, accuracy, precision, system suitability, robustness and range. From the results it is concluded that as per USP method, HPLC is less time consuming and cost reducing, and the results obtained are more accurate, precise and reproducible as compared to UV.1 Keywords: HPLC, Clonazepam, USP, ICH guidelines, Validation
Publication date: 01/08/2020

https://ijbpas.com/pdf/2020/August/MS_IJBPAS_2020_5130.pdf

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https://doi.org/10.31032/IJBPAS/2020/9.8.5130