Stability of Phytopharmaceuticals: Regulatory requirements, HPTLC/HPLC fingerprinting MCQs With Answer

Stability of Phytopharmaceuticals: Regulatory requirements, HPTLC/HPLC fingerprinting MCQs With Answer

This quiz set is crafted for M.Pharm students studying advanced pharmaceutical analysis, focusing on stability requirements and chromatographic fingerprinting of phytopharmaceuticals. It covers regulatory expectations (ICH and regional guidelines), stability study design, forced degradation, packaging impact, and key analytical strategies using HPTLC and HPLC. Emphasis is placed on method development, validation parameters, fingerprint interpretation, and identification of degradation products. These MCQs reinforce conceptual understanding and practical decision-making needed for designing stability protocols and generating reliable chromatographic fingerprints for complex botanical matrices, preparing students for research, regulatory submissions, and quality control of herbal medicines.

Q1. Which ICH guideline primarily outlines the stability testing requirements for new drug substances and products, including phytopharmaceuticals?

• ICH Q1A(R2) — Stability Testing of New Drug Substances and Products
• ICH Q2(R1) — Validation of Analytical Procedures
• ICH Q3B(R2) — Impurities in New Drug Products
• ICH Q6A — Specifications: Test Procedures and Acceptance Criteria

Correct Answer: ICH Q1A(R2) — Stability Testing of New Drug Substances and Products

Q2. In designing accelerated stability studies for a phytopharmaceutical, which condition is commonly used to simulate accelerated aging?

• 25°C ± 2°C / 60% RH ± 5% RH
• 30°C ± 2°C / 65% RH ± 5% RH
• 40°C ± 2°C / 75% RH ± 5% RH
• 5°C ± 3°C

Correct Answer: 40°C ± 2°C / 75% RH ± 5% RH

Q3. Which of the following best describes “forced degradation” studies for phytopharmaceuticals?

• Long-term storage at recommended conditions to determine shelf-life
• Intentional exposure to extreme conditions to produce degradation products for method development
• Routine microbiological challenge testing for preservatives
• Comparative stability testing of different batches under market conditions

Correct Answer: Intentional exposure to extreme conditions to produce degradation products for method development

Q4. For HPTLC fingerprinting of a plant extract, which step is most critical to ensure reproducible band patterns?

• Use of gradient elution in HPLC
• Consistent sample application volume and application technique
• Heating the plate to 120°C before development
• Applying a colorimetric reagent prior to development

Correct Answer: Consistent sample application volume and application technique

Q5. When validating an HPLC method for quantifying a marker compound in a herbal extract, which validation parameter ensures the method can separate the marker from its degradation products?

• Accuracy
• Specificity (selectivity)
• Precision
• Limit of Detection (LOD)

Correct Answer: Specificity (selectivity)

Q6. Which detector is most useful in HPLC for obtaining UV spectra to help identify co-eluting phytoconstituents and degradants?

• Refractive index detector (RID)
• Fluorescence detector (FLD)
• Photodiode array detector (PDA)
• Electrochemical detector (ECD)

Correct Answer: Photodiode array detector (PDA)

Q7. In HPTLC, densitometry is used primarily to:

• Separate compounds by polarity
• Visually enhance bands before derivatization
• Quantify analytes by measuring reflected or transmitted light intensity
• Change mobile phase composition during run

Correct Answer: Quantify analytes by measuring reflected or transmitted light intensity

Q8. Which parameter is most indicative that a chromatographic system is performing acceptably before sample analysis?

• System suitability tests such as theoretical plates and tailing factor
• Only calibration curve linearity
• Ambient lab temperature recorded
• Volume of mobile phase left in reservoir

Correct Answer: System suitability tests such as theoretical plates and tailing factor

Q9. For complex botanical matrices, “chemical fingerprinting” primarily aims to:

• Measure a single active marker concentration only
• Provide a holistic chromatographic profile to assess identity and consistency
• Replace all pharmacopoeial tests for impurities
• Determine microbial limits

Correct Answer: Provide a holistic chromatographic profile to assess identity and consistency

Q10. During forced degradation, which stress condition is specifically intended to assess photostability?

• Exposure to acidic and alkaline hydrolysis
• Storage at 40°C/75% RH
• Exposure to specified light intensity and duration following ICH Q1B
• Oxidative stress with hydrogen peroxide

Correct Answer: Exposure to specified light intensity and duration following ICH Q1B

Q11. In HPLC method development for phytopharmaceuticals, which approach helps reduce matrix effects from co-extracted polyphenols?

• Using a high flow rate irrespective of column dimensions
• Including a selective sample cleanup step like solid-phase extraction (SPE)
• Omitting the mobile phase buffer to simplify composition
• Only using UV detection at 254 nm

Correct Answer: Including a selective sample cleanup step like solid-phase extraction (SPE)

Q12. A fingerprint chromatogram should be validated for which attribute to support its use in quality control of herbal drugs?

• Only system suitability
• Reproducibility and specificity of characteristic peaks
• Time of day when analysis is performed
• Theoretical mass balance calculations

Correct Answer: Reproducibility and specificity of characteristic peaks

Q13. In HPTLC, which mobile phase property most strongly affects resolution of phenolic compounds?

• Stationary phase particle size only
• pH and polarity of the mobile phase
• Plate thickness exclusively
• Temperature of plate storage before development

Correct Answer: pH and polarity of the mobile phase

Q14. For herbal stability studies, why is packaging selection included in the stability protocol?

• Packaging aesthetics influence patient compliance
• Packaging can alter exposure to moisture, oxygen and light affecting stability
• Packaging only matters for parenterals, not phytopharmaceuticals
• Packaging materials are only tested after expiry

Correct Answer: Packaging can alter exposure to moisture, oxygen and light affecting stability

Q15. When using HPLC-PDA for fingerprinting, how can you use spectral data to distinguish overlapping peaks?

• Ignore spectra and rely on retention time only
• Use spectral comparison and peak purity analysis to detect co-elution
• Increase injection volume to resolve overlap
• Switch to RID to avoid spectral complexity

Correct Answer: Use spectral comparison and peak purity analysis to detect co-elution

Q16. Which validation parameter determines the smallest amount of marker compound that can be reliably quantified in a phytopharmaceutical matrix?

• Limit of Detection (LOD)
• Specificity
• Limit of Quantification (LOQ)
• Accuracy

Correct Answer: Limit of Quantification (LOQ)

Q17. In stability-indicating HPLC methods, how are degradation products typically identified after chromatographic separation?

• By comparing retention times only with other peaks
• Using hyphenated techniques like LC-MS or LC-PDA with spectral matching and mass data
• By assuming all minor peaks are impurities unrelated to main compound
• By simple visual inspection of chromatograms

Correct Answer: Using hyphenated techniques like LC-MS or LC-PDA with spectral matching and mass data

Q18. A major challenge in HPTLC fingerprinting of multi-component botanical extracts is:

• Excessive sensitivity compared to HPLC
• Band diffusion and poor resolution of closely related compounds
• Difficulty in detecting non-chromophoric compounds by densitometry exclusively
• Inability to run multiple samples in parallel

Correct Answer: Band diffusion and poor resolution of closely related compounds

Q19. According to regulatory expectations, what must be demonstrated for a phytopharmaceutical stability claim of 24 months at room temperature?

• Only a single batch tested under one condition
• Long-term stability data from at least three primary batches and supporting accelerated data
• Only accelerated data is acceptable
• Microbial limits data alone

Correct Answer: Long-term stability data from at least three primary batches and supporting accelerated data

Q20. In HPLC fingerprinting, principal component analysis (PCA) and other chemometric tools are used primarily to:

• Visually enhance bands on HPTLC plates
• Reduce data dimensionality and classify samples based on chromatographic patterns
• Replace the need for method validation
• Determine exact molecular structures without MS data

Correct Answer: Reduce data dimensionality and classify samples based on chromatographic patterns

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