scholarly journals A QUALITY BY DESIGN APPROACH FOR DEVELOPMENT OF SIMPLE AND ROBUST REVERSED PHASE STABILITY INDICATING HPLC METHOD FOR ESTIMATION OF IBRUTINIB AND ITS IMPURITIES

2019 ◽  
Vol 12 (03) ◽  
pp. 1434-1445
Author(s):  
Somana Siva Prasad ◽  
G.V. Krishna Mohan ◽  
A. Naga Babu
Keyword(s):  
Phase Stability ◽  
Quality By Design ◽  
Reversed Phase ◽  
Hplc Method ◽  
Design Approach ◽  
Stability Indicating ◽  
Quality By Design Approach

Integrated Quality by Design (QbD) Approach for Stability Indicating RP-HPLC Method for Estimation of Tadalafil Hydrochloride in Bulk Drug and Pharmaceutical Formulations

2020 ◽  
Vol 16 ◽  
Author(s):  
Prajakta H Patil ◽  
B.M. Gurupadayya ◽  
P.D. Hamrapurkar
Keyword(s):  
Quality Control ◽  
Mobile Phase ◽  
Quality By Design ◽  
Degradation Products ◽  
Hplc Method ◽  
Design Approach ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Quality By Design Approach ◽  
Bulk Drug

Background: In the view of the current FDA standardization and product quality control criteria, Quality by design approach for analytical methods gaining importance to develop a robust analytical method. A new Quality by Design approach by RP-HPLC was developed and validated for the quantification and purification of Tadalafil hydrochloride and its tablet formulations. Objective: The objective of the study was to develop and validate a simple, robust, and accurate method by QbD approach for detection Tadalafil hydrochloride and its degradation products in bulk drug and tablet formulation. Materials and Methods: The chromatographic separation was performed on JASCO Crest Pack RPC18 column (250mm×4.6mm, 5μm) with a mobile phase consisting of a mixture of mobile phase A: Acetonitrile: Methanol (40:20 v/ v) and mobile phase B: 0.01M Ammonium acetate in water adjusted pH 3.50± 0.05 with glacial acetic acid with 1.0ml/ min flow rate at 285nm. Box-Behnken's three-level 3 factorial design was employed to create and analyze a "Design Space" (DoE). This design was statistically analyzed by ANOVA, counter-plot, and 3D response surfaces plots which demonstrated that the model is statically significant. The developed method was validated as per ICH guidelines Q2 (R1). Results and Discussion: The tadalafil hydrochloride showed good regression (R2>0.9995) within test ranges, and the percent recovery was found to be 98% in marketed formulation. Conclusion: The method was found to be highly specific without the interference of impurities and degradation products of tadalafil hydrochloride. For quantification and routine quality control of tadalafil and its marketed formulation, the stability-indicating the RP-HPLC method could thus be extended.

scholarly journals QUALITY BY DESIGN APPROACH TO DEVELOP STABILITY INDICATING REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD DEVELOPMENT FOR AMBROXOL

2021 ◽  
pp. 44-49
Author(s):  
SUFIYAN AHMAD ◽  
PRANIT KHABIYA ◽  
TATIYA AU ◽  
ABDURL RAHEMAN BAKHSHI
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Quality By Design ◽  
Reversed Phase ◽  
Design Approach ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Limit Of Quantitation ◽  
Quality By Design Approach

Objective: As per requisition of current regulatory requirements, simple, rapid and sensitive method by 33 factorial quality by design approach was established and validated for Ambroxol (AMB) by reversed-phase high-performance liquid chromatography (RP-HPLC). Methods: A simple RP-HPLC method has been developed and validated with different parameters such as linearity, precision, repeatability, limit of detection (LOD), limit of quantitation (LOQ), accuracy as per International Conference for Harmonisation guidelines (Q2R1). Statistical data analysis was done for data obtained from different aliquots Runs on Agilent Tech. Gradient System with Auto injector, ultraviolet (UV) diode-array detection and Gradient Detector. Results: Equipped with Reverse Phase (Agilent) C18 column (4.6 mm × 100 mm; 2.5 μm), a 20 μl injection loop and UV730D Absorbance detector at 244 nm wave length and running chemstation 10.1 software and drugs along with degradants were separated via Methanol: (0.1% orthophosphoric acid) Water (75:25) of pH 3 as mobile phase setting flow rate 0.7 ml/min at ambient temperature the retention time of AMB were found to be 4.85 min. The industrialized method was found linear over the concentration range of 10–50 μg/ml for AMB while the LOD and LOQ of AMB was found to be 0.5174–0.2739 μg/ml, analytical method that concluded. Conclusion: There are no interfering peaks underperformed degradation conditions. Therefore, a sensitive, robust, accurate, and stability indicating method was developed with high degree of practical utility.

Analytical Quality by Design Approach for a Stability-Indicating Method to Determine Apixaban and Its Related Impurities

2019 ◽  
Vol 83 (1) ◽  
pp. 65-75 ◽  
Author(s):  
Jéssica B. Ellwanger ◽  
Nathalie Ribeiro Wingert ◽  
Nadia Maria Volpato ◽  
Cássia Virginia Garcia ◽  
Elfrides E. S. Schapoval ◽  
...  
Keyword(s):  
Quality By Design ◽  
Design Approach ◽  
Analytical Quality ◽  
Stability Indicating ◽  
Related Impurities ◽  
Stability Indicating Method ◽  
Quality By Design Approach

Using an innovative quality-by-design approach for the development of a stability-indicating UPLC/Q-TOF-ESI-MS/MS method for stressed degradation products of imatinib mesylate

RSC Advances ◽  
2016 ◽  
Vol 6 (16) ◽  
pp. 13050-13062 ◽  
Author(s):  
Zhihui Ren ◽  
Xiaoxi Zhang ◽  
Haiyuan Wang ◽  
Xinghua Jin
Keyword(s):  
Simultaneous Determination ◽  
Imatinib Mesylate ◽  
Quality By Design ◽  
Degradation Products ◽  
Design Approach ◽  
Design Expert ◽  
Stability Indicating ◽  
Esi Ms ◽  
Quality By Design Approach

Chromatography modeling softwares (DryLab®2000 plus and Design Expert®​8.0.6) were used to develop a stability indicating UPLC/Q-TOF-ESI-MS/MS method for the simultaneous determination of stressed degradation products of imatinib mesylate.​

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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