Content uniformity in granules for aceclofenac controlled release (CR) tablets determined using near-infrared spectroscopy and wide area illumination (WAI) raman spectroscopy |
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Authors: | Young-Ah Woo |
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Institution: | Korea United Pharm. INC., Chungnam 339-841, Korea. wooy219@yahoo.com |
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Abstract: | Non-destructive and rapid determination methods were developed for aceclofenac controlled release (CR) tablets. The tablet
is composed of two layers, rapid release and controlled release (CR) layers. The pharmaceutical manufacturing process for
CR granules is very critical for dissolution control of CR tablets. During processing, a rapid and nondestructive method to
test content uniformity of aceclofenac granules is required. Chemometrics using near-infrared (NIR) and Raman spectroscopy
have found significant uses in quantitative analysis of pharmaceutical products in complex matrixes. Most of the pharmaceutical
products can be measured directly with little or no sample preparation using these spectroscopic methods. This study showed
NIR and wide area illumination Raman spectroscopy with partial least squares (PLS) was very effective for the content uniformity
of granules while high performance liquid chromatography (HPLC), a conventional method, was time-consuming and ineffective
for real time control. This study showed that on-line control of content uniformity control of aceclofenac CR tablets can
be achieved using NIR and Raman spectroscopy. |
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