What question did this study set out to answer?

To comprehensively validate a stability-indicating RP-HPLC method for the simultaneous quantification of six B-complex vitamins according to ICH Q2(R2) and USP guidelines.

August 16, 2026Open Access

Validation and Pharmaceutical Application of a Stability-Indicating Rp-HPLC Method for Simultaneous Determination of Vitamin-B Complex Components as Per Ich Q2 (R2)

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Authors

DJDr. Heena Patel2* Janki Joshi1

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Implication

Analytical validation study demonstrates an accurate stability-indicating RP-HPLC assay for multi-vitamin formulations, indicating its viability for pharmaceutical quality control.

Key Points

To comprehensively validate a stability-indicating RP-HPLC method for the simultaneous quantification of six B-complex vitamins according to ICH Q2(R2) and USP guidelines.
Assessed system suitability, specificity, linearity, accuracy, precision, LOD/LOQ, robustness, and solution stability for vitamins B1, B2, B3, B6, B9, and B12.
Conducted forced degradation testing under acidic, alkaline, oxidative, thermal, and photolytic stress conditions to evaluate peak resolution of intact analytes from degradation products.
Applied the validated analytical procedure to quantitatively determine vitamin content in a commercial combined pharmaceutical product.
Met all ICH Q2(R2) criteria with linear calibration curves across working ranges (R² > 0.999), recovery rates between 98% and 102%, and intra-day and inter-day precision (%RSD) below 2%.
Successfully resolved all forced degradation products from intact vitamin peaks across all tested stress conditions.
Quantified all six vitamins in a marketed formulation within 98.9% to 101.2% of label claims with low analytical variability.

Cite This Study

Dr. Heena Patel2* Janki Joshi1 (2026) studied this question.

synapsesocial.com/papers/6a817980f2fb91fc834aca6b https://doi.org/10.5281/zenodo.21916514

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Implication

Analytical validation study demonstrates an accurate stability-indicating RP-HPLC assay for multi-vitamin formulations, indicating its viability for pharmaceutical quality control.

Validation and Pharmaceutical Application of a Stability-Indicating Rp-HPLC Method for Simultaneous Determination of Vitamin-B Complex Components as Per Ich Q2 (R2)

Discussion

Member takes

Implication

Key Points

Cite This Study

Validation and Pharmaceutical Application of a Stability-Indicating Rp-HPLC Method for Simultaneous Determination of Vitamin-B Complex Components as Per Ich Q2 (R2)

Discussion

Member takes

Implication

Key Points

Cite This Study

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