Compatibility Determination of Drug-Polymer, Drug-Excipient & Drug-Intravenous Admixtures Using Chemometric-assisted UVspectrophotometry

Author(s): Amir Ibrahim Mohamed*, Amal Abd-Elaal El-Khamery, Mohamed Ismail Herry, Alaa Ibrahim Mohamed

Journal Name: Current Pharmaceutical Analysis

Volume 16 , Issue 2 , 2020


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Graphical Abstract:


Abstract:

Purpose: A new multivariate chemometric approach was developed for fast and economic compatibility determinations of ranitidine hydrochloride (as model drug) with certain pharmaceutical; polymers (Alginate & Chitosan), excipient (Lactose) and intravenous fluids (Dextrose, Ringer & Dextrose/ Ringer). Binary mixtures of the drug and each item were prepared and investigated by chemometric- assisted UV- spectrophotometry as well as by HPLC reference method.

Methods: Five drug concentration levels (0.004-0.025mg/ml) of test-mixtures were used and the average drug recovery percent after two and seven days of storage from initial concentration was determined. Physico-chemical techniques including DSC, XRD, & FTIR were also performed to investigate the nature of the observed drug-additive interactions.

Results: UV-chemometric and HPLC results showed that ranitidine stability in mixture aqueous solutions appears to be concentration dependent. The ranitidine content remained greater than 90% in alginate & chitosan test mixtures at all used drug concentrations (0.004-0.025mg/ml), while in lactose, dextrose, ringer & dextrose/ringer test mixtures fell below 90% at low drug concentrations (0.004- 0.009mg/ml), which suggests more ranitidine compatibility with alginate & chitosan rather than the other additives.

Conclusion: The developed chemometric method, employing UV absorbance data successfully used as simple, rapid, and economic alternative tool in drug-additive compatibility determinations.

Keywords: Ranitidine hydrochloride, drug-Polymer compatibility, drug-excipient compatibility, drug-intravenous admixtures compatibility, UV-chemometric, HPLC.

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Article Details

VOLUME: 16
ISSUE: 2
Year: 2020
Published on: 23 January, 2020
Page: [125 - 142]
Pages: 18
DOI: 10.2174/1573412914666181011142351
Price: $65

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