Introduction to Pharmaceutical Analysis PDF
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Summary
This document provides an overview of introduction to pharmaceutical analysis focusing on key terms, classifications, components, and calibration methods. It also covers figures of merit, validation, and applications to clinical considerations.
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**OUTLINE** [[DEFINITION OF TERMS IN ANALYTICAL CHEMISTRY]](#definition-of-terms-in-analytical-chemistry) [[CLASSIFICATION OF ANALYSIS]](#classification-of-analysis) [[COMPONENTS OF ANALYTICAL METHOD]](#components-of-analytical-method) [[INTRODUCTION TO CALIBRATION METHODS]](#introduction-to-cal...
**OUTLINE** [[DEFINITION OF TERMS IN ANALYTICAL CHEMISTRY]](#definition-of-terms-in-analytical-chemistry) [[CLASSIFICATION OF ANALYSIS]](#classification-of-analysis) [[COMPONENTS OF ANALYTICAL METHOD]](#components-of-analytical-method) [[INTRODUCTION TO CALIBRATION METHODS]](#introduction-to-calibration-methods) [[FIGURES OF MERIT]](#figures-of-merit) [[INTRODUCTION TO PHARMACEUTICAL ANALYSIS (VALIDATION OF ANALYTICAL METHODS)]](#introduction-to-pharmaceutical-analysis-validation-of-analytical-methods) [[INTRODUCTION TO PHARMACEUTICAL ANALYSIS (CLINICAL PERSPECTIVE IN ANALYTICAL CHEMISTRY)]](#introduction-to-pharmaceutical-analysis-clinical-perspective-in-analytical-chemistry) **NOTE** **This font color is for PPT content and figure/table descriptions.** ---------- ----------------------------------------------------------------------- **This font color is for extra information from the professor.** DEFINITION OF TERMS IN ANALYTICAL CHEMISTRY =========================================== ANALYTICAL CHEMISTRY -------------------- - ANALYTE ------- - - - ASSAY ----- - INTERFERENCE ------------ - SAMPLE MATRIX ------------- - BLANK ----- - - CLASSIFICATION OF ANALYSIS ========================== CLASSICAL METHOD ---------------- - *Figure 1. Illustration of the classical method* INSTRUMENTAL METHOD ------------------- - COMPONENTS OF ANALYTICAL METHOD =============================== ![](media/image11.png) *Fig 2. Monograph for Assay of Ascorbic Acid tablets* - - - - - - - - - - - - - - - SELECTION OF ANALYTICAL METHOD ------------------------------ - - - - - - - - - - - - - - - - - - - - - - - INTRODUCTION TO CALIBRATION METHODS =================================== INSTRUMENT CALIBRATION ---------------------- - - - - - *Figure 3. Tools used for calibration* - ### EXTERNAL STANDARD METHOD - - - - - - - - - - - - ![](media/image7.png) - - - *Figure 4. 5 Standard Solution of Increasing Concentration* - - - - - - - ![](media/image33.jpg) *Fig 6. Sample Calibration Curve for Standard Solutions of External Standard Method* - - - ### INTERNAL STANDARD METHOD *Figure 7. Internal Standard Method* - - - - - - ![](media/image3.png) *Fig 8. Formula for response factor, F.* *Fig 9. Response of the sample in HPLC* - - - - ![](media/image1.png) *Figure 10. Example of calibration curve for internal standard method* ### STANDARD ADDITION - - - - - - - - *Figure 11 Steps in Spiking for Multiple Standard Method* - ![](media/image28.png) *Figure 12/ Calibration Curve for Spiking method* - Formula: Where: S~1~ = instrument response k = proportionality constant V~s~ = volume of standard added C~s~ = concentration of standard solution Vx = sample aliquot C~x~ = concentration of the sample V~t~ = total volume of diluted solution (V~s~)~0~ = volume of standard at zero signal - - - - - - *Figure 13. Steps in Spiking for Single Standard Method* - ![](media/image27.png) Where: S~1~ = instrument response of sample only S~2~ = instrument response of sample + standard V~s~ = volume of standard added C~s~ = concentration of standard solution V~x~ = volume of aliquot C~x~ = concentration of the sample FIGURES OF MERIT ================ - - - - - - - - - - - - ACCURACY -------- *Figure 14. Dartboard for Accuracy* - - - - - - - - - - - - - - PRECISION --------- ![](media/image15.png) *Fig 15. Dartboard for Precision* - - - - - - - - - - - - - - - - SPECIFICITY ----------- - ![](media/image16.png) *Figure 17. Chromatogram showing the peak height of substances* - - - - - SELECTIVITY ----------- - - - SENSITIVITY ----------- - - - - - - - - ![](media/image14.png) *Figure 18. Calibration curve for Quercetin Standard Solutions* - - - - LIMIT OF DETECTION (LOD) ------------------------ - *Figure 19. An example showing LOD (Highest Peak)* - - ![](media/image18.png) *Figure 20. Solving a random drug for Sample* CONCENTRATION RANGE AND LINEARITY --------------------------------- - - - - *Figure 21. Illustration of a curve that measures linearity and range* - - - - - - - - - - - VALIDATION ---------- - - - INTRODUCTION TO PHARMACEUTICAL ANALYSIS (VALIDATION OF ANALYTICAL METHODS) ========================================================================== PARAMETERS ---------- ![](media/image13.png) *Figure 22. Parameters to consider in conducting pharmaceutical analysis* - - - - - - - - - *Figure 23. Acceptance criteria to determine test passability* - INTRODUCTION TO PHARMACEUTICAL ANALYSIS (CLINICAL PERSPECTIVE IN ANALYTICAL CHEMISTRY) ====================================================================================== - - - APPLICATION IN TDM ------------------ - - - - - - - - ![](media/image24.png) *Figure 24. Process for reaching dosage decisions with TDM (Kang and Lee, 2009)* **[REFERENCES:]** Collins Dictionary. (2010). Analytical chemistry definition and meaning. Retrieved from https://www.collinsdictionary.com/dictionary/english/analytical-chemistry BYJU\'S. (n.d.). Analytical chemistry - Description, methods, techniques. Retrieved from https://byjus.com/chemistry/analytical-chemistry/ American Chemical Society. (n.d.). Analytical Chemistry. Retrieved from https://www.acs.org/careers/chemical-sciences/areas/analytical-chemistry.html LibreTexts. (2021). The Vocabulary of Analytical Chemistry. Retrieved from https://chem.libretexts.org/Bookshelves/Analytical\_Chemistry/Analytical\_Chemistry\_2.1\_(Harvey)/03:\_The\_Vocabulary\_of\_Analytical\_Chemistry Eurachem. (2011). Terminology in Analytical Measurement. Retrieved from https://www.eurachem.org/images/stories/Guides/pdf/TAM\_2011\_Final\_web.pdf