scholarly journals APPLICATION OF QUALITY BY DESIGN APPROACH IN UV-VIS SPECTROSCOPY METHOD DEVELOPMENT FOR SIMULTANEOUS ESTIMATION OF SAXAGLIPTIN HCL AND METFORMIN HCL IN ACTIVE PHARMACEUTICAL INGREDIENT

2021 ◽  
Vol 10 (6) ◽  
Keyword(s):  
Method Development ◽  
Quality By Design ◽  
Active Pharmaceutical Ingredient ◽  
Spectroscopy Method ◽  
Design Approach ◽  
Simultaneous Estimation ◽  
Vis Spectroscopy ◽  
Quality By Design Approach ◽  
Metformin Hcl

scholarly journals Reverse Phase-High Performance Liquid Chromatography method development and validation for estimation of efavirenz by Quality by Design approach

2019 ◽  
Vol 9 (1-s) ◽  
pp. 319-330
Author(s):  
Santosh A Waghmare ◽  
Arun M Kashid
Keyword(s):  
High Performance ◽  
Method Development ◽  
Quality By Design ◽  
Active Pharmaceutical Ingredient ◽  
Hplc Method ◽  
Design Approach ◽  
Main Peak ◽  
Chromatography Method ◽  
Design Expert ◽  
Quality By Design Approach

Quality by design (QbD) refers to the achievement of certain predictable quality with desired and predetermined specifications. A very useful component of the QbD is the understanding of factors and their interaction effects by a desired set of experiments by using software (design expert 8). The present study describes the development of a comprehensive science and risk based HPLC method which is given by design expert 8 and subsequent validation for the analysis of Efavirenz active pharmaceutical ingredient (API) using a quality by design approach. An efficient experimental design based on systematic scouting of all four key components of the RP‐HPLC method (column, pH, mobile phase and flow rate) is presented. The described method was linear. R2=0.9998. The precision, ruggedness and robustness values were also within the prescribed limits (<1% for system precision and <2% for other parameters). Chromatographic peak purity results indicated the absence of co‐eluting peaks with the main peak of Efavirenz. The proposed method can be used for routine analysis of Efavirenz in quality control laboratories. Keywords: Quality by design, HPLC, Efavirenz, design expert 8.

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.

scholarly journals HPLC method development for fampridine using Analytical Quality by Design approach

2020 ◽  
Vol 70 (4) ◽  
pp. 465-482
Author(s):  
Béla Kovács ◽  
Francisc Boda ◽  
Ibolya Fülöp ◽  
István Székely-Szentmiklósi ◽  
Éva Katalin Kelemen ◽  
...  
Keyword(s):  
Method Development ◽  
Quality By Design ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Design Approach ◽  
Limit Of Quantification ◽  
Elution Time ◽  
Pharmaceutical Dosage Form ◽  
Quality By Design Approach ◽  
Hplc Method Development

AbstractOffering a systematic and multivariate analysis of the analytical procedure, development and validation of HPLC methods using Quality by Design approach are in the limelight of current research trends. A new, experimental design-aided HPLC method for fampridine was developed and preliminarily validated according to current in-force international guidelines for linearity, accuracy, robustness and precision.The method offers a high throughput sample analysis, with an elution time of 2.9 minutes, and signal detection without excipient interference performed at 262 nm. The method proved to be linear between 1–15 µg mL−1 (R2= 0.9996). The mean recovery was found to be 98.7 ± 1.9 % in the tested range of 2.5–7.5 µg mL−1. Low RSD values (< 1 %) were obtained for both model, intra- and inter-day precision. The limit of detection and limit of quantification were 0.24 and 0.78 µg mL−1, resp. The method proved to be applicable for active substance assay in a pharmaceutical dosage form.

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