Application of analytical quality by design approach in method development for the simultaneous estimation of levocetrizine hydrochloride and montelukast sodium in their combined dosage form

2020 ◽  
Vol 33 (2) ◽  
pp. 119-129
Author(s):  
Jina A. Desai ◽  
Praful P. Dedhiya ◽  
Hitika B. Patel ◽  
Ashish D. Mishra ◽  
Shailesh A. Shah
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Quality By Design ◽  
Design Approach ◽  
Simultaneous Estimation ◽  
Analytical Quality ◽  
Montelukast Sodium ◽  
Quality By Design Approach

Estimation of Glycopyrrolate by Analytical Quality by Design Supported Difference UV Spectrophotometric Method

2018 ◽  
Vol 11 (5) ◽  
pp. 4244-4248
Author(s):  
Sagar Suman Panda ◽  
Ravi Kumar B V V ◽  
Divyakalpa Panda ◽  
Raja Kumar V
Keyword(s):  
Spectrophotometric Method ◽  
Method Development ◽  
Quality By Design ◽  
Scanning Speed ◽  
Sampling Interval ◽  
Design Approach ◽  
Sample Cell ◽  
Analytical Quality ◽  
Absorbance Maximum ◽  
Quality By Design Approach

A novel difference UV spectrophotometric method was developed and validated for estimation of glycopyrrolate (GLP) in injection formulations using analytical quality by design approach. GLP shows two different absorbance maxima in 0.1M HCl and 0.1M NaOH. Principle of difference spectroscopy was utilized to avoid the variation in absorbance maximum and amplitude of analyte solutions were measured keeping analyte in 0.1M HCl in reference cell and analyte in 0.1M NaOH in sample cell. The amplitude was measured considering maxima at 219nm and minima at 233nm. Further, analytical quality by design approach proved worthy by ensuring method robustness prior to method development. Scanning speed and sampling interval were the two variables which were studied for the robustness purpose using an experimental design. The method validation studies were carried out to evaluate linearity, accuracy, precision, sensitivity etc. The method was applied successfully for estimation of GLP in bulk and present in injections.  

Systematic Method Development with an Analytical Quality‐by‐Design Approach Supported by Fusion QbD and UPLC – MS

2021 ◽  
pp. 375-384
Author(s):  
Falk‐Thilo Ferse ◽  
Detlev Kurth ◽  
Tran N. Pham ◽  
Fadi L. Alkhateeb ◽  
Paul Rainville
Keyword(s):  
Method Development ◽  
Quality By Design ◽  
Design Approach ◽  
Analytical Quality ◽  
Systematic 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

scholarly journals Analytical quality by design approach to RP-HPLC method development and validation for simultaneous estimation of esomeprazole and naproxen in modified-release dosage form

2022 ◽  
Vol 8 (1) ◽  
Author(s):  
Khandokar Farjana Urmi ◽  
Md. Saddam Nawaz ◽  
S. M. Ashraful Islam
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Quality By Design ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Solution Stability ◽  
Modified Release ◽  
Analytical Quality ◽  
Rp Hplc ◽  
Development And Validation

Abstract Background The present work describes the development and validation of a new, specific, accurate, and precise stability-indicating RP-HPLC method for the simultaneous estimation of Esomeprazole (ESP) and Naproxen (NAP) in modified-release bi-layer tablet dosage form. Analytical Quality by Design concept was implemented through the method development exercise to establish the robustness of the method. Results Method development was performed on C18, 250 × 4.6 mm ID, and 5 µm particle size column with 10 µl injection volume using a photodiode array (PDA) detector to monitor the detection at 280 nm. The mobile phase consisted of the buffer: methanol at a ratio of 50: 50 (v/v), and the flow rate was maintained at 1.5 ml/min, and the column oven temperature was maintained at 30 °C. The retention times for NAP and ESP were found 5.9 ± 0.1 and 8.9 ± 0.1 min, respectively. The method was validated in terms of system suitability, specificity, accuracy, linearity, precision, and solution stability. Linearity was observed over the range of concentration 8–12 µg/ml for ESP and 200–300 µg/ml for NAP, and the correlation coefficient (R2) was found excellent > 0.999. The method was specific to ESP and NAP, and the peak purity was found 99.97% for ESP and 100.00% for NAP. The method was precise and had %RSD less than 2. Recovery study for accuracy with placebo was found in the range of 99.63–100.36% for ESP and 99.91–100.43% for NAP. Conclusion This proposed fast, reliable, cost-effective method can be used as a quality control tool for the simultaneous determination of Esomeprazole and Naproxen in routine laboratory analysis. Graphical Abstract

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