Quantitative characterisation of extended release tablets with quetiapine using NIR chemometric methods

This study aims to develop and validate NIR-chemometric methods for quantifying the API (quetiapine) and two excipients in extended-release tablets without sample preparation. The calibration samples were prepared following an experimental design with three variables (quetiapine, HPMC and microcrystalline cellulose) and five levels (concentration 80-90-100-110-120% of API).

The validation set included three concentration levels (90-100-110%). The best calibration algorithms have used the same pre-treatment method (SNV), and different factors: 7 PLS factors (R² -0,966 and RMSEP-6,84) for quetiapine, 8 PLS factors (R²-0,927 and RMSEP 6,84) for HPMC and 3 PLS factors (R²-0,983 and RMSEP-7,26) for microcrystalline cellulose. The methods were fully validated according to the ICH guidance using these calibration models. Regarding the trueness of the methods, the recovery was between 98.51 and 99.43 for quetiapine, between 98.61 and 100.85 for HPMC, and between 100.61 and 101.78 for microcrystalline cellulose. According to data obtained, the accuracy profile was ± 5 for quetiapine and HPMC, and ± 6 for microcrystalline cellulose.

Linearity profile was also in establish intervals at accuracy and the R2 value was 0.983 for quetiapine, 0.948 for HPMC and 0.997 for microcrystalline cellulose. In conclusion, the developed NIR-chemometric methods have suitable reproducibility, accuracy, linearity and can be used for quantitative characterisation of extended-release tablets with quetiapine, with any sample preparation

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Materials
Quetiapine fumarate, the active pharmaceutical ingredient (API) was supplied by PharmaZell – India.
Two diluents, lactose monohydrate (Tablettose 80 from Meggle – Germany) and microcrystalline cellulose – CMC (Avicel PH-102, from Chemo Pharma – Austria), were used in the formulation. During wet granulation, a 10% solution of polyvinylpyrrolidone (Kollidon 30 produced by BASF – Germany) was used as binder. Also, two matrix-forming excipients, based on hydroxypropyl methylcellulose HPMC, were used: Methocel K 100 M and Methocel K 100 LV (supplied by Colorcon – UK). Extra-granular excipients were, besides Avicel PH-102, colloidal silicon dioxide

Article information: Teodora DRĂGAN, Luca Liviu RUS, A. MUNTEAN, A.L. VONICA-TINCU, Ioan TOMUȚĂ. Romanian Journal of PHARMACEUTICAL PRACTICE, Vol. XIV, No. 2 (57), Year 2021