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Pharma 2018
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E u r o p e a n C o n g r e s s o n
Pharma
A u g u s t 1 3 - 1 4 , 2 0 1 8
P a r i s , F r a n c e
American Journal of Pharmacology and Pharmacotherapeutics
ISSN: 2393-8862
C
ontent uniformity (CU) is a critical quality attribute in tablet manufacturing process. The active pharmaceutical ingredient
(API) is usually determined by 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 and transmittance methods for the determination of the ibuprofen content (mg) for the content uniformity
for ibuprofen tablet. Partial least squares (PLS) models for the NIR reflectance and transmittance was constructed by using
calibration laboratory tablets with different ibuprofen (IBU) contents spanning from 146.47 mg to 243.91 mg. The predictive
performance of the proposed methods was evaluated by traditional chemometric criteria. The corresponding values for the
root mean square error of prediction (RMSEP) were equal to 0.96% and 1.83% for NIR reflectance and transmittance methods,
respectively; besides using the chemometric criteria to compare analytical performance of proposed NIR methods. Moreover, the
proposed NIR methods were 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).
shawky0225@gmail.comApplication of NIR spectroscopy for content uniformity
determination of intact tablets: comparison of reflection and
transmission modes of NIR spectroscopy
Ahmed Shawky Abouzaid
1, 3
, Eman S Elzanfaly
2
, Ahmed E El
Gindy
1
, Stephen W Hoag
3
and Ahmed Ibrahim
1, 3
1
Misr International University, Cairo, Egypt
2
Cairo University, Cairo, Egypt
3
University of Maryland, Baltimore, Maryland, USA
Ahmed Shawky Abouzaid et al., Am J Pharmacol Pharmacother 2018, Volume 5
DOI: 10.21767/2393-8862-C1-003