title: Investigation of Drug-Polymer Compatibility Using Chemometric-Assisted UV-Spectrophotometry.
abstract: A simple chemometric-assisted UV-spectrophotometric method was used to study the compatibility of clindamycin hydrochloride (HC1) with two commonly used natural controlled-release polymers, alginate (Ag) and chitosan (Ch). Standard mixtures containing 1:1, 1:2, and 1:0.5w/wdrug-polymer ratios were prepared and UV scanned. A calibration model was developed with partial least square (PLS) regression analysis for each polymer separately. Then, test mixtures containing 1:1w/wdrug-polymer ratios with different sets of drug concentrations were prepared. These were UV scanned initially and after three and seven days of storage at 25 °C. Using the calibration model, the drug recovery percent was estimated and a decrease in concentration of 10% or more from initial concentration was considered to indicate instability. PLS models with PC3 (for Ag) and PC2 (for Ch) showed a good correlation between actual and found values with root mean square error of cross validation (RMSECV) of 0.00284 and 0.01228, and calibration coefficient (R²) values of 0.996 and 0.942, respectively. The average drug recovery percent after three and seven days was 98.1 ± 2.9 and 95.4 ± 4.0 (for Ag), and 97.3 ± 2.1 and 91.4 ± 3.8 (for Ch), which suggests more drug compatibility with an Ag than a Ch polymer. Conventional techniques including DSC, XRD, FTIR, and in vitro minimum inhibitory concentration (MIC) for (1:1) drug-polymer mixtures were also performed to confirm clindamycin compatibility with Ag and Ch polymers.
authors.affiliation: Pharmaceutics and industrial pharmacy, Military Medical Academy, Cairo 00202, Egypt. miroami@gmail.com.
authors.forename: Amir Ibrahim
authors.initials: AI
authors.lastname: Mohamed
authors.affiliation: Pharmaceutics and industrial pharmacy, Military Medical Academy, Cairo 00202, Egypt. amr.abdmotagaly@gmail.com.
authors.forename: Amr Mohamed Elsayed
authors.initials: AM
authors.lastname: Abd-Motagaly
authors.affiliation: Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, King Abdulaziz University, Jeddah 21589, Saudi Arabia. osama712000@gmail.com.
authors.forename: Osama A A
authors.initials: OA
authors.lastname: Ahmed
authors.affiliation: Medical services Department, Cairo 00202, Egypt. dr.suzanamin@gmail.com.
authors.forename: Suzan
authors.initials: S
authors.lastname: Amin
authors.affiliation: Faculty of Pharmacy, Cairo University, Cairo 11562, Egypt. alaa081866@miuegypt.edu.eg.
authors.forename: Alaa Ibrahim
authors.initials: AI
authors.lastname: Mohamed Ali
keywords: chitosan; clindamycin HCl; drug–polymer compatibility; partial least squares regression (PLS); sodium alginate