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28404

CONTENT UNIFORMITY DETERMINATION OF IBUPROFEN INTACT TABLETS BY REFLECTANCE NIR SPECTROSCOPY

Article

Last updated: 22 Jan 2023

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Abstract

Content uniformity (CU) is a critical quality attribute in tablet manufacturing process. The active pharmaceutical ingredient (API) is usually determined off-line techniques such as, high performance liquid chromatography (HPLC) which is a slow, destructive technique and requires sample preparation. Therefore, Near Infrared (NIR) spectroscopy was employed as a process analytical technology (PAT) tool to determine the API and consequently the content uniformity of tablets. NIR spectroscopy is a fast, non-destructive technique and requires minimal sample preparation. The purpose of this work was to develop and validate NIR reflectance method for the determination of the ibuprofen content (mg) for the content uniformity for ibuprofen tablet. Partial least squares (PLS) model for the NIR reflectance was constructed by using calibration laboratory tablets with different ibuprofen (IBU) contentsspanning from 146.47 mg to 243.91 mg. The predictive performance of the proposed method was evaluated by traditional chemometric criteria. The corresponding values for the root mean square error of prediction (RMSEP) were equal to 0.96% for NIR reflectance method. Besides, the proposed NIR method was successfully validated and implemented for the determination of the content uniformity for three batches that represent three levels of IBU content (160 mg, 200 mg and 240 mg).

DOI

10.21608/ajps.2017.28404

Keywords

Content uniformity, Ibuprofen, NIR reflectance, PLS regression model

Authors

First Name

Ahmed

Last Name

Abouzaid

MiddleName

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Affiliation

Analytical Chemistry Department,Faculty of Pharmacy, Misr International University, Km 28 Cairo Ismailia Road, Cairo, Egypt

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Volume

55

Article Issue

1

Related Issue

5065

Issue Date

2017-03-01

Receive Date

2019-03-06

Publish Date

2017-03-01

Page Start

13

Page End

29

Print ISSN

1110-1644

Online ISSN

2535-1958

Link

https://ajps.journals.ekb.eg/article_28404.html

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https://ajps.journals.ekb.eg/service?article_code=28404

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2

Type

Original Article

Type Code

518

Publication Type

Journal

Publication Title

Al-Azhar Journal of Pharmaceutical Sciences

Publication Link

https://ajps.journals.ekb.eg/

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Article

Created At

22 Jan 2023