Tablet evaluation-Analytical Methods
Near Infra red Spectroscopic method-Quantitative Analysis
Two Major advances:
- Development of Instrumentation that enabled transmission analysis
- Guidelines publication for validation of analytical methods
Quantitative NIR Analysis:
NIR analysis combines both automation and high speed. After the assay is validated one can generate single unit analyses in less than 1 minute.
American Society for Testing and Materials (ASTM) standards assist in validating NIR analytical method. There are no other guidelines at present for validation of this method.
ICH and some other guidelines were integrated along with ASTM to gratify GMP regulations and validate NIR method for tablets.
Criteria for Validation of NIR method:
Specificity: Principal component analysis
Accuracy: Difference between estimated value and reference value
Precision: Reproducibility and Repeatability
Linearity: Evaluation fro sequential dependence. Each error is compared with that of the before and after when the date is put in an order of the predicted NIR values.
T test for the slope: It determines if there is any significant difference between the actual slope and theoretical slope of the calibration set
Range: 80-120% for assay and
70-30% for content uniformity testing
In order to validate the method in 80-120% range of label claim actual samples of production along with development batches were used.
It becomes easy to assay many finished units from a batch instead of selecting few, random samples as it takes less than a minute to calculate the results.
Clinical supply identification
Incoming raw material Identification
Content Uniformity Testing
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1.Satinder Ahuja and Stephen Scypinski, HANDBOOK OFMODERN PHARMACEUTICAL ANALYSIS, volume 3, 2001;chapter 6 ,pages252-256
2. Gilpin, R. K. and Pachla, L. A. Pharmaceutical and related drugs. Anal. Chem. 71:217R-233R,
3. Krstulovic, A. M. and Lee, C. R. Defining drug purity through chromatographic and related
methods: current status and perspectives. J. Chrom. B. 689(1):137-153, 1997.
4. Adamovics, J. A., Ed. Chromatographic Analysis of Pharmaceuticals, 2nd ed. Dekker, New