Application of Quality Risk Assessment and DoE-Based Enhanced Analytical Quality by Design Approach to Development of Chromatography Method for Estimation of Combined Pharmaceutical Dosage Form of Five Drugs

2020 ◽  
Author(s):  
Pintu B Prajapati ◽  
Kajal Jayswal ◽  
Shailesh A Shah
Keyword(s):  
Risk Management ◽  
High Performance ◽  
Quality By Design ◽  
Simultaneous Estimation ◽  
Analytical Quality ◽  
Chromatography Method ◽  
Quality Risk Management ◽  
Pharmaceutical Industries ◽  
Quality Risk ◽  
Hptlc Method

Abstract The high-performance liquid chromatography method was only reported for simultaneous estimation of aspirin, simvastatin, ramipril, atenolol and hydrochlorothiazide in polycap capsule. High-performance thin-layer chromatography (HPTLC) method is now accepted as a method of analysis by many pharmaceutical industries and included as an official method in monographs of pharmacopeias of many countries. Hence, HPTLC method was developed and validated for the estimation of polycap capsule using enhanced analytical quality by design based on principles of quality risk management and design of experiment (DOE). Quality risk management was performed by the identification and assessment of risky method parameters. DoE was carried out by Placket–Burman screening design and Box–Behnken response surface methodology using resolution and tailing factor as critical method attributes. Method operable design region was navigated for optimization and development of the method. The developed method was validated as per ICH Q2 (R1) guideline. The method was found accurate, specific, precise and sensitive for the said estimation. The developed method was applied for the assay of polycap capsule and results were found in good agreement with the labeled claim. The developed method can be used as an alternative to reported HPLC methods for quality control of polycap capsule.

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.

Quality Risk Management and Quality by Design for the Development of Diclofenac Sodium Intra-articular Gelatin Microspheres

2020 ◽  
Vol 21 (4) ◽  
Author(s):  
Alexandros Nakas ◽  
Athanasia M. Dalatsi ◽  
Afroditi Kapourani ◽  
Konstantinos N. Kontogiannopoulos ◽  
Andreana N. Assimopoulou ◽  
...  
Keyword(s):  
Risk Management ◽  
Quality By Design ◽  
Diclofenac Sodium ◽  
Gelatin Microspheres ◽  
Quality Risk Management ◽  
Quality Risk

Stability Indicating Simultaneous Estimation of Cetirizine Hydrochloride and Phenylephrine Hydrochloride in Combined tablet formulation by using HPTLC- Densitometric method

2021 ◽  
pp. 2467-2471
Author(s):  
M.R. Bodhankar ◽  
S.J. Wadher ◽  
T.M. Kalyankar ◽  
Anitha K
Keyword(s):  
High Performance ◽  
Heat Exposure ◽  
Calibration Plot ◽  
Simultaneous Estimation ◽  
Chromatography Method ◽  
Phenylephrine Hydrochloride ◽  
Solid Dosage ◽  
Cetirizine Hydrochloride ◽  
Layer Chromatography ◽  
Hptlc Method

The new simple, precise, rapid, selective, high performance thin layer chromatography method has been developed for simultaneous estimation of cetirizine hydrochloride and phenylephrine hydrochloride in its combined solid dosage form. The HPTLC method was performed on precoated silica gel G60 F254 plates with, Toluene: Methanol: Ammonia (8: 2: 1, v/v/v) as optimum mobile phase. The plates were developed in 6.00× 0.30mm at room temperature. The developed plates were scanned and quantified at their absorption at 224 nm for CET and PHE respectively. The drugs were satisfactorily resolved with Rf = 0.36± 0.001 for CET and 0.65±0.004 for PHE. Calibration plot was linear between 100-600 ng/ spot for CET and 200-1200 ng/ spot for PHE. This HPTLC method is sensitive, economical, less time consuming than other chromatographic procedures. It can become important tool for analysis of combined solid dosage from. In addition to this results acid exposure, base exposure, oxidative exposure, neutral exposure, photolysis and dry heat exposure is carried out.

Regulation of Nanotechnology-Based Products Subject to Health Regulations: Application of Quality by Design (QbD) and Quality Risk Management (QRM)

2021 ◽  
pp. 319-347
Author(s):  
André Luís Dias ◽  
Natália Noronha Ferreira ◽  
Leonardo Miziara Barboza Ferreira ◽  
Liliane Neves Pedreiro ◽  
Aline Martins dos Santos ◽  
...  
Keyword(s):  
Risk Management ◽  
Quality By Design ◽  
Quality Risk Management ◽  
Quality Risk ◽  
Health Regulations ◽  
Regulation Of Nanotechnology

DoE-Based Analytical Quality Risk Management for Enhanced AQbD Approach to Economical and Eco-Friendly RP-HPLC Method for Synchronous Estimation of Multiple FDC Products of Antihypertensive Drugs

2021 ◽  
Author(s):  
Pintu Prajapati ◽  
Ankita Patel ◽  
Shailesh Shah
Keyword(s):  
Risk Management ◽  
Antihypertensive Drugs ◽  
Hplc Method ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Analytical Quality ◽  
Quality Risk Management ◽  
Rp Hplc ◽  
Dose Combination ◽  
Quality Risk

Abstract According to the literature review, numerous chromatographic methods have been published for estimation of fixed-dose combination products of telmisartan but no reverse-phase high-pressure liquid chromatographic (RP-HPLC) method has been published yet for synchronous estimation of fixed-dose combination (FDC) products of telmisartan to save time, cost and solvent for analysis. Hence, an economical and eco-friendly RP-HPLC method has been developed for synchronous estimation of multiple FDC products of antihypertensive drugs using the quality risk management (QRM) and DoE-based enhanced analytical quality by design approach. The analytical-QRM was started with the identification of potential method risk parameters followed by their risk assessment by risk priority number ranking and filtering. The identified critical method parameters were optimized using the DoE-based central composite design. The method operable design range was navigated and the control strategy was framed for control and mitigation of risk throughout the life-cycle of the developed method. The method was developed using Shimpack Octadecyl silane (ODS) C18 column and acetonitrile-1.0%v/v triethylamine in water (pH 6.0; 45 + 55, %v/v). The developed method was validated as per the International Council for Harmonization Q2 (R1) guideline. The developed method was applied for the analysis of seven different antihypertensive dosage forms. The developed RP-HPLC method can be used as an eco-friendly, robust and economical alternative analytical tool to several published methods for estimation of FDC products of antihypertensive drugs in the pharmaceutical industry.

Risk and DoE-Based Analytical Failure Mode Effect Analysis (AFMEA) to Simultaneous Estimation of Montelukast Sodium and Bilastine by HPTLC Method Using Enhanced AQbD Approach

2021 ◽  
Author(s):  
Pintu Prajapati ◽  
Jayesh Tamboli ◽  
Ashish Mishra
Keyword(s):  
Risk Management ◽  
Failure Mode ◽  
Failure Modes ◽  
Simultaneous Estimation ◽  
Effect Analysis ◽  
Quality Risk Management ◽  
Montelukast Sodium ◽  
Mode Effect ◽  
Quality Risk ◽  
Failure Mode Effect Analysis

Abstract The fixed-dose combination (FDC) of montelukast sodium (MLS) and bilastine (BIL) is used for monotherapy in the patient with seasonal allergic rhinoconjuctivitis and asthma. According to the upcoming ICH (International Council for Harmonization) Q14 guideline, the development of the analytical method by the implementation of the Analytical Quality by Design (AQbD) approach based on principles of Quality Risk Management (QRM) and design of experiments (DoE) would be a regulatory requirement for the registration of new drug substance and product in ICH countries. Hence, a robust high-performance thin layer chromatography method has been developed, which was not previously reported for simultaneous estimation of MLS and BIL using risk and DoE-based enhanced AQbD approach. The analytical failure mode effect analysis (AFMEA) was started with the identification of potential analytical failure modes followed by their effect analysis by RPN ranking and filtering method. The DoE-based AFMEA was applied for optimization of high-risk analytical failure modes by central composite design using Design-Expert software. The method operable design ranges and control strategy was set for quality risk management throughout the lifecycle of the developed method. The developed method was validated as per ICH Q2 (R1) guideline. The method was applied for the assay of FDC, and results were found in compliance with the labeled claim.

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