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Statistical considerations in biosimilar assessment using biosimilarity index

In-vitro Release of Rapamycin from a Thermosensitive Polymer for the Inhibition of Vascular Smooth Muscle Cell Proliferation

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Citations : 4363

Journal of Bioequivalence & Bioavailability received 4363 citations as per Google Scholar report

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A validated HPLC method for estimation of Loratadine from pharmaceutical preparations
3rd World Congress Bioavailability & Bioequivalence
March 26-28, 2012 Marriott Hotel & Convention Centre, Hyderabad, India

Chougule G. K. and Dr. Zubaidha P. K.

Posters: J Bioequiv Availab

Abstract:

A rapid and simple HPLC procedure was developed for rapid quality control analysis of pharmaceutical preparations containing the antihistaminic drug loratadine. The separation was performed on a column packed with ODS C-18 (Kromasil 4.6mm x 25cm, 5μm) adopting UV detection at 248 nm using a flow rate of 1 ml/min with isocratic elution at room temperature. The optimized mobile phase consisted of Methanol & water. The developed method was validated in terms of specificity, linearity, interday and intraday precision, stability of solutions and accuracy. Percent recovery was calculated and was found to be in range 99-101%. Linearity was assessed in the range of 2-24 μg/ml in plasma with a correlation coefficient of greater than 0.999. The intra-and inter-day coefficient of variation of the assay method were calculated. The values were between 98-102%. The method requires a minimum of sample handling and is rapid (10 min), and reproducible (R.S.D. < 2.0%)

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