Definition and scope of pharmaceutical analysis MCQs With Answer

Definition and scope of pharmaceutical analysis MCQs With Answer covers key concepts B.Pharm students must master for ensuring drug quality, safety and regulatory compliance. Pharmaceutical analysis defines methods to identify, quantify and evaluate active pharmaceutical ingredients, impurities and excipients using techniques such as titration, UV‑Visible spectroscopy, chromatography (HPLC/GC) and mass spectrometry. The scope includes sample preparation, method development, validation parameters (accuracy, precision, linearity, LOD/LOQ), stability testing and adherence to pharmacopeial and ICH guidelines. Strong understanding of analytical principles supports quality control, stability‑indicating assays and regulatory submissions. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary definition of pharmaceutical analysis?

• Study of drug marketing strategies
• Study of methods for identification, assay and purity of drugs
• Study of clinical trial design
• Study of pharmacodynamics and pharmacokinetics

Correct Answer: Study of methods for identification, assay and purity of drugs

Q2. Which technique is most suitable for separating non‑volatile components in a mixture?

• Gas chromatography (GC)
• High performance liquid chromatography (HPLC)
• Voltammetry
• Flame photometry

Correct Answer: High performance liquid chromatography (HPLC)

Q3. Which parameter describes the closeness of repeated measurements to each other?

• Accuracy
• Linearity
• Precision
• Specificity

Correct Answer: Precision

Q4. Limit of detection (LOD) is best defined as:

• The highest concentration that can be measured accurately
• The lowest amount of analyte that can be detected but not necessarily quantified
• The concentration where calibration curve deviates from linearity
• The amount required for full recovery in extraction

Correct Answer: The lowest amount of analyte that can be detected but not necessarily quantified

Q5. Which ICH guideline primarily deals with validation of analytical procedures?

• ICH Q1A
• ICH Q2(R1)
• ICH Q3B
• ICH Q7

Correct Answer: ICH Q2(R1)

Q6. In UV‑Visible spectrophotometry, Beer‑Lambert law relates absorbance to:

• Wavelength and solvent polarity
• Concentration and path length
• Temperature and pressure
• pH and ionic strength

Correct Answer: Concentration and path length

Q7. Which is a stability‑indicating method?

• A test that only measures total content without separating degradants
• A method that separates and quantifies drug and its degradation products
• A method used exclusively for raw material identification
• A test that measures pH only

Correct Answer: A method that separates and quantifies drug and its degradation products

Q8. What does system suitability testing verify before an HPLC run?

• Marketing status of drug
• Instrument readiness and chromatographic performance
• Regulatory approval of method
• Sample synthesis pathway

Correct Answer: Instrument readiness and chromatographic performance

Q9. Which parameter is NOT part of method validation per ICH Q2?

• Ruggedness
• Specificity
• Therapeutic efficacy
• Limit of quantitation (LOQ)

Correct Answer: Therapeutic efficacy

Q10. Specificity in pharmaceutical analysis refers to:

• Ability to produce same result across labs
• Ability to measure analyte unequivocally in presence of other components
• Degree of agreement between measured and true value
• Range over which method is linear

Correct Answer: Ability to measure analyte unequivocally in presence of other components

Q11. Which extraction technique is commonly used for preparing biological samples for HPLC?

• Solid phase extraction (SPE)
• Simple filtration through paper
• Steam distillation
• Crystallization

Correct Answer: Solid phase extraction (SPE)

Q12. What is the main advantage of using an internal standard in quantitative analysis?

• Increases chromatographic resolution
• Corrects for sample loss and injection variability
• Eliminates need for calibration curve
• Makes method non‑specific

Correct Answer: Corrects for sample loss and injection variability

Q13. Which titration type is used to determine chloride content in a drug substance?

• Complexometric titration
• Precipitation titration (Mohr method)
• Redox titration
• Acid‑base titration

Correct Answer: Precipitation titration (Mohr method)

Q14. Robustness testing of an analytical method assesses:

• Effect of deliberate small variations in method parameters
• Inter‑laboratory reproducibility only
• How well method detects impurities at trace level
• Stability of analyte in formulation packaging

Correct Answer: Effect of deliberate small variations in method parameters

Q15. In chromatography, retention time is best described as:

• Time taken for mobile phase to pass through column
• Time from injection until analyte peak appears
• Time required to equilibrate detector
• Time for sample preparation

Correct Answer: Time from injection until analyte peak appears

Q16. Which detector is most commonly paired with GC for structural identification?

• UV‑Visible detector
• Mass spectrometer (MS)
• Refractive index detector
• Fluorescence detector

Correct Answer: Mass spectrometer (MS)

Q17. What does LOQ represent in analytical chemistry?

• Lowest concentration that can be detected
• Lowest concentration that can be quantified with acceptable precision and accuracy
• Highest concentration of analyte in linear range
• Limit beyond which instrument is damaged

Correct Answer: Lowest concentration that can be quantified with acceptable precision and accuracy

Q18. Which physicochemical property primarily influences retention in reverse‑phase HPLC?

• Analyte volatility
• Hydrophobicity (lipophilicity)
• Optical rotation
• Presence of radioactive isotopes

Correct Answer: Hydrophobicity (lipophilicity)

Q19. What is the purpose of a blank in analytical assays?

• Provide a standard containing known analyte amount
• Correct for instrument baseline and reagent contributions
• Act as internal standard
• Stabilize the mobile phase

Correct Answer: Correct for instrument baseline and reagent contributions

Q20. Which of the following best defines accuracy?

• Closeness of test results to the true value
• Reproducibility of results under same conditions
• Speed of obtaining results
• Number of peaks resolved in chromatography

Correct Answer: Closeness of test results to the true value

Q21. A validation parameter that evaluates method performance over a specified concentration interval is called:

• Specificity
• Range
• Limit of detection
• System suitability

Correct Answer: Range

Q22. Which mobile phase change would generally increase retention time for a polar analyte in reverse‑phase HPLC?

• Increase organic solvent proportion
• Decrease organic solvent proportion
• Increase flow rate
• Use a shorter column

Correct Answer: Decrease organic solvent proportion

Q23. Forced degradation studies are performed to:

• Accelerate pharmacodynamic effects
• Demonstrate method is stability‑indicating and identify degradation pathways
• Replace stability studies entirely
• Reduce impurity formation in synthesis

Correct Answer: Demonstrate method is stability‑indicating and identify degradation pathways

Q24. Which analytical parameter assesses repeatability between different analysts and laboratories?

• Precision (inter‑laboratory or reproducibility)
• Specificity
• Linearity
• LOD

Correct Answer: Precision (inter‑laboratory or reproducibility)

Q25. In titrimetry, an equivalence point is:

• The point where indicator changes color
• Theoretical point where stoichiometric amounts of titrant and analyte react
• The time at which titration started
• The point where pH is zero

Correct Answer: Theoretical point where stoichiometric amounts of titrant and analyte react

Q26. Which pharmacopeial document provides official methods and specifications for medicines?

• Monograph
• Patent
• Marketing application summary
• Manufacturer’s promotional brochure

Correct Answer: Monograph

Q27. Which ionization technique is commonly used in LC‑MS for polar, thermally labile pharmaceuticals?

• Electron ionization (EI)
• Electrospray ionization (ESI)
• Field ionization
• Thermal ionization

Correct Answer: Electrospray ionization (ESI)

Q28. What does the term ‘assay’ typically refer to in pharmaceutical analysis?

• Identification of impurities only
• Quantitative determination of active ingredient content
• Visual inspection of packaging
• Measurement of dissolution medium pH

Correct Answer: Quantitative determination of active ingredient content

Q29. Which is the correct formula for percent relative standard deviation (RSD)?

• (Standard deviation / Mean) × 100
• (Mean / Standard deviation) × 100
• (Standard deviation + Mean) / 100
• (Range / Mean) × 100

Correct Answer: (Standard deviation / Mean) × 100

Q30. During calibration curve construction, which practice ensures linearity is properly assessed?

• Using a single standard concentration
• Using at least five concentration levels spanning the expected range
• Ignoring low concentration points
• Using unreplicated single measurements only

Correct Answer: Using at least five concentration levels spanning the expected range

G S Sachin

I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.

Mail- Sachin@pharmacyfreak.com