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Quality Risk Management Based: Analytical Quality by Design Approach to Eco-Friendly and Versatile Chromatography Method for Simultaneous Estimation of Multiple Fixed-Dose-Combination Products of Anti-Diabetic Drugs

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Abstract

Purpose

The chromatography methods such as HPLC, HPTLC etc. were developed for simultaneous estimation of multiple fixed-dose combination products of metformin hydrochloride which need single chromatography condition to save solvent consumption. The method was developed by the implementation of analytical quality by design approach based on principles of quality risk management (QRM) and design of experiments (DoE) as per regulatory requirements.

Methods

QRM was applied for the analysis of twenty potential method risk parameters using the Ishikawa diagram and quality risk assessment according to ICH Q9 guideline. DoE was applied by Taguchi OA screening design and Box-Behnken response surface analysis method. Method operable design range was navigated for optimisation of critical method risk parameters as per the analytical target profile for development of the method. The developed method was applied for the analysis of three different fixed-dose combination products of metformin hydrochloride.

Results

By the QRM process, seven method risk parameters were found critical for the development of the method. After the Taguchi screening design, the main effect of mobile phase composition, %w/v of ammonium acetate and saturation time was found to be significant. The results of the Box-Behnken design showed a quadratic relationship between CMPs and CMAs. The developed method was found to be specific, accurate and precise. The results of the assay were found in good agreement with the labelled claim.

Conclusion

The developed method can analyse three different fixed-dose combination products of metformin hydrochloride which required three different chromatography methods. Hence, the method is versatile and eco-friendly.

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References

  1. Sharma HL, Sharma KK. Principle of Pharmacology. 2nd ed: Paras Medical Publisher; 2011. p. 636–41.

  2. Fixed-dose combination products of metformin hydrochloride. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fixed-dose-combinations-co-packaged-drug-products-and-single-entity-versions-previously-approved. Accessed on date 19/09/2020.

  3. Metformin hydrochloride drug information in Drug bank. https://www.drugbank.ca/drugs/DB00331. Accessed on date 29 July 2020.

  4. Pioglitazone hydrochloride drug information in Drug bank. https://www.drugbank.ca/drugs/DB01132. Accessed on date 29th July 2020.

  5. Gliclazide drug information in Drug bank. https://www.drugbank.ca/drugs/DB01120. Accessed on date 29 July 2020.

  6. Repaglinide drug information in Drug bank. https://www.drugbank.ca/drugs/DB00912. Accessed on date 29 July 2020.

  7. Indian Pharmacopoeia, The Indian Pharmacopoeia Commission, Ghaziabad, Govt. of India, Ministry of Health and Family Welfare, 2014; volume I and II: 503,2186–2188.

  8. United States Pharmacopoeia 41 National Formulary 36, United States Pharmacopoeial Convention Inc., Rockville MD, USA, 2018; Volume I:914–915, 2614–2624.

  9. British Pharmacopoeia, The Department of Health, Great Britain. London, United Kingdom: Medicine and Healthcare product Regulatory Agency.2008; volume II:1375–1376, 1653-1654.

  10. International Council for Harmonization guidelines Q2 (R1), Q8 (R2), Q9, Q10; ICH Harmonised Tripartite Guideline; 2009.

  11. Reddy CH, Mubeen G, Mamta H. HPTLC method for estimation of metformin hydrochloride. Biomed Pharmacol J. 2008;1(2):445–8 http://biomedpharmajournal.org/?p=505.

    CAS  Google Scholar 

  12. Pritam J, Devendra G, Anjali G. Stability indicating HPTLC densitometric method for determination of metformin hydrochloride in tablet formulation. J Pharm BioSci. 2013;1(2):51–8. https://doi.org/10.5530/ijper.51.2s.44.

    Article  CAS  Google Scholar 

  13. Modi DK, Patel BH. Simultaneous estimation of metformin hydrochloride and pioglitazone HCL in tablet formulation by HPTLC method. J Liq Chromatogr Relat Technol. 2013;36(5):618–27. https://doi.org/10.4103/0250-474X.43010.

    Article  CAS  Google Scholar 

  14. Patil V, Kale S, Sahara P, Vithaldas S. Simultaneous HPTLC analysis of gliclazide and metformin hydrochloride in bulk and tablet dosage form. J Sci Innov Res. 2014;3(3):325–31.

    Google Scholar 

  15. Pavar J, Sonawane S, Chhajed S, Kshirsagar S. Development and validation Of RP-HPLC method for simultaneous estimation of metformin HCl and gliclazide. Asian J Pharm Anal. 2016;6(3):151–4. https://doi.org/10.5958/2231-5675.2016.00024.7.

    Article  Google Scholar 

  16. Ahir KB, Patelia EM, Shah A. Simultaneous estimation of metformin hydrochloride and repaglinide in pharmaceutical formulation by HPTLC – densitometry method. J Chromat Separation Techniq. 4(1):166. https://doi.org/10.4172/2157-7064.1000166.

  17. Shirode AR, Maduskar PD, Deodhar MS, Kadam VJ. RP-HPLC and HPTLC methods for simultaneous estimation of metformin hydrochloride and vildagliptin from bulk and marketed formulation: development and validation. J Pharm Res Int. 2014;4(20):2370–86. https://doi.org/10.9734/BJPR/2014/12820.

    Article  CAS  Google Scholar 

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Acknowledgements

Authors are thankful to the principal of Maliba Pharmacy College affiliated with Uka Tarsadia University for providing necessary facilities to carry out the research work.

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Authors and Affiliations

  1. Maliba Pharmacy College, Uka Tarsadia University, Bardoli-Mahuva Road, Tarsadi, Taluko – Mahuva, Surat, Gujarat, 394350, India

    Pintu B. Prajapati, Khushbu Radadiya & Shailesh A. Shah

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  1. Pintu B. Prajapati
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  2. Khushbu Radadiya
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  3. Shailesh A. Shah
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Correspondence to Pintu B. Prajapati.

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Prajapati, P.B., Radadiya, K. & Shah, S.A. Quality Risk Management Based: Analytical Quality by Design Approach to Eco-Friendly and Versatile Chromatography Method for Simultaneous Estimation of Multiple Fixed-Dose-Combination Products of Anti-Diabetic Drugs. J Pharm Innov 17, 111–128 (2022). https://doi.org/10.1007/s12247-020-09506-5

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