Quality Risk Management Based: Analytical Quality by Design Approach to Eco-Friendly and Versatile Chromatography Method
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ORIGINAL ARTICLE
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 Pintu B. Prajapati 1 & Khushbu Radadiya 1 & Shailesh A. Shah 1 Accepted: 23 September 2020 # Springer Science+Business Media, LLC, part of Springer Nature 2020
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. Keywords Analytical target profile . Design of experiments (DoE) . Quality risk management (QRM) . Metformin hydrochloride . HPTLC (high-performance thin layer chromatography)
Introduction Metformin hydrochloride is the most commonly used drug for the treatment of non-insulin-dependent (type-2) alone and in fixed-dose combination with other anti-diabetic drugs. According to guidance that has been prepared by the Division
* Pintu B. Prajapati [email protected] 1
Maliba Pharmacy College, Uka Tarsadia University, Bardoli-Mahuva Road, Tarsadi, Taluko – Mahuva, Surat, Gujarat 394350, India
of Antiviral Drug Products in the Center for Drug Evaluation and Research (CDER)-USFDA in cooperation with the Office of Regulatory Policy, CDER, numbers of fixed-dose combination products of metformin hydrochloride with pioglitazone, repaglinide and gliclazide are available in the local market for the treatment of non-insul
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