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11.
Development and Validation of a Simple UV Method for In Vitro
Determination of Amoxicillin Trihydrate in New Gastroretentive
Dosage Form
V. K.
Pawar*, G. Garg, R. Awasthi, Nitin Kumar and G. T. Kulkarni
Department of Pharmaceutical Technology, Meerut Institute of
Engineering and Technology, NH- 58, 250002, Uttar Pradesh, India
*Corresponding Author: V. K. Pawar, Ph. +91-9756354246, E-mail:
vivekpharmaperson@gmail.com
Abstract:
A simple, rapid, sensitive and robust UV method was developed
and validated to measure the amount of amoxicillin in order to
assess drug release profiles and drug–excipients compatibility
studies for new Gastroretentive Dosage Form and its subsequent
stability studies. The working conditions of the method were
investigated and optimized. The linearity for concentrations 5
to 30 μg/ml was established and the system founded to obey
Beer-Lambert’s law in this concentration range. Intra and
inter-day precision were less than 2.5 %. The limits of
detection (LOD) and quantitation were 0.58 and 1.77 μg/ml. The
determination of the active ingredient was not interfered by the
excipients of the products. Samples were stable in the release
media (37 ± 0.5 οC). The proposed method is simple,
sensitive, accurate and suitable for quality control
applications.
KEYWORDS: Amoxicillin,
Gastroretentive Dosage Form, Simulated gastric fluid, H. pylori.
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