Implementation of QRM and DoE-Based Quality by Design Approach to VEER Chromatography Method for Simultaneous Estimation of Multiple Combined Dosage Forms of Paracetamol

2020 ◽  
Author(s):  
Pintu Prajapati ◽  
Hilomi Shah ◽  
Shailesh A Shah
Keyword(s):  
Quality By Design ◽  
Dosage Forms ◽  
Design Approach ◽  
Simultaneous Estimation ◽  
Chromatography Method ◽  
Quality By Design Approach

DoE and Risk-Based DMAIC Principle for Implementation of Enhanced Analytical Quality by Design Approach to Multipurpose-Chromatography Method for Simultaneous Estimation of Multiple Fixed-Dose Combination Products of Aspirin

2021 ◽  
Author(s):  
Pintu B Prajapati ◽  
Kajal V Jayswal ◽  
Shailesh A Shah
Keyword(s):  
Quality By Design ◽  
Design Approach ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Simultaneous Estimation ◽  
Analytical Quality ◽  
Chromatography Method ◽  
Dose Combination ◽  
Quality By Design Approach ◽  
Risk Parameters

ABSTRACT Background Numerous RP-HPLC and HPTLC methods have been reported for estimation of fixed-dose combination (FDC) products of aspirin with anti-hypertensive and anti-lipidemic drugs. Each FDC of aspirin needed separate and dedicated chromatographic condition for its analysis. No Chromatography method has been reported yet for simultaneous estimation of FDC products of aspirin using the single chromatography condition. Objectives Hence, the multipurpose-HPTLC method was developed for simultaneous estimation of some FDC products of aspirin using enhanced analytical quality by design approach based on DoE and risk-based DMAIC principle to save solvent, cost and time of analysis. Methods The risk-based DMAIC process was carried out with identification of potential method risk parameters and their assessment using RPN ranking and filtering. The DoE-based DMAIC process was carried out by the implementation of fractional factorial and full factorial design. Results The mobile phase composition and volume of modifier were found to be critical method risk parameters for resolution of all peaks. The developed method was found to be validated, and assay results of all FDC products of aspirin were found to be in good agreement with their respective labelled claim. Conclusion The developed method is found to be solvent, cost and time saving and also fulfilled the analytical requirements of many reported chromatography methods. Hence, the developed method is the multipurpose-chromatography for analysis of FDC products of aspirin. Highlights DoE and Risk-based DMAIC principle to development of the multipurpose-chromatography method. Application of the developed method for the estimation of eight different FDC products of aspirin

QUALITY BY DESIGN APPROACH (QBD) FOR THE SIMULTANEOUS ESTIMATION OF CANDESARTAN CILEXETIL AND AMLODIPINE BESYLATE BY RP–HPLC

INDIAN DRUGS ◽  
2020 ◽  
Vol 57 (08) ◽  
pp. 41-52
Author(s):  
Ankita Kamli ◽  
Megha Shah ◽  
Madhuri Hinge
Keyword(s):  
Experimental Design ◽  
Flow Rate ◽  
Quality By Design ◽  
Candesartan Cilexetil ◽  
Design Approach ◽  
Simultaneous Estimation ◽  
Chromatographic Technique ◽  
Amlodipine Besylate ◽  
Quality By Design Approach ◽  
Liquid Chromatographic

A revers phase liquid chromatographic technique has been developed for the separation and determination of candesartan cilexetil and amlodipine besylate using QbD (Quality by Design) approach. The present method was optimised by introducing experimental design approach to identify the chromatographic conditions for adequate separation quality and minimal analysis duration. The relation between independent variables and critical quality attributes is given by experimental design methodology. The separation was achieved on shim-pack solar C18 type column (250 mm × 4.6 mm, 5 µm) as stationary phase; acetonitrile: phosphate buffer pH 6.8 (82:18, v/v); 1.0 ml/min as flow rate; detection wavelength 235 nm. The chromatographic efficiency was investigated for the factorial effect of percentage organic phase and flow rate and finely optimized by employing factorial design experiment. The method was validated and was found to be accurate, precise and robust.

Quality Risk Management-Based AQbD Approach to Development of VEER Chromatography Method for the Estimation of Multiple Combined Formulations of Anti-Hypertensive Drugs

2020 ◽  
Author(s):  
Pintu B Prajapati ◽  
Mukti A Thakor ◽  
Kunjan B Bodiwala ◽  
Shailesh A Shah
Keyword(s):  
Risk Management ◽  
Dosage Forms ◽  
Simultaneous Estimation ◽  
Chromatography Method ◽  
Pharmaceutical Dosage Forms ◽  
Quality Risk Management ◽  
Screening Design ◽  
Quality Risk ◽  
Quality By Design Approach ◽  
Risk Parameters

Abstract Background A number of chromatography methods for estimating combined dosage forms of telmisartan have been published in the literature, but each combined dosage form needs separate chromatography conditions for analysis. Objective The versatile, economical, eco-friendly, and robust chromatographic method has been developed for simultaneous estimation of multiple combined pharmaceutical dosage forms of anti-hypertensive drugs using the analytical quality by design approach based on principles of quality risk management (QRM) and design of experiment (DoE). Method Analytical QRM was performed by identifying probable method risk parameters and risk assessment for the development of the method. DoE was performed by Taguchi Orthogonal Array (OA)  screening design and Box-Behnken response surface design using Design-Expert software (trial version). Chromatographic separation was performed using silica gel 60 GF254 as stationary phase and toluene:ethyl acetate:methanol:glacial acetic acid (5.5 + 2 + 1 + 0.2, v/v/v/v) as a mobile phase keeping saturation time of 15 min. The developed method was applied for the assay of six combined pharmaceutical dosage forms of anti-hypertensive drugs. Results The developed method was found to be validated for accuracy, precision, specificity, linearity, LOD, LOQ, and robustness as per ICH guideline. The results of the assay were found in good agreement with the labelled claim. Conclusions The developed method can be applied for analysis and quality control of multiple combined dosage forms of telmisartan. Highlights A QRM and DoE-based AQbD approach was applied for development of chromatography method for simultaneous estimation of multiple combined dosage forms of telmisartan. The developed method was successfully applied for simultaneous estimation of six different multiple combined dosage forms of temisrtan.

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