Quality assessment and RP-HPLC method development for estimation of curcuminoids in Curcuma longa: A Quality by Design approach

2020 ◽  
pp. 1-8
Author(s):  
Vishakha Parab Gaonkar ◽  
Kirankumar Hullatti
Keyword(s):  
Quality Assessment ◽  
Method Development ◽  
Quality By Design ◽  
Curcuma Longa ◽  
Hplc Method ◽  
Design Approach ◽  
Rp Hplc ◽  
Quality By Design Approach ◽  
Hplc Method Development

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.

scholarly journals An analytical “quality by design” approach in RP-HPLC method development and validation for reliable and rapid estimation of irinotecan in an injectable formulation

2021 ◽  
Vol 71 (1) ◽  
pp. 57-79 ◽  
Author(s):  
Navya Ajitkumar Bhaskaran ◽  
Lalit Kumar ◽  
M Sreenivasa Reddy ◽  
Girish K Pai
Keyword(s):  
Method Development ◽  
Quality By Design ◽  
Potassium Phosphate ◽  
Hplc Method ◽  
Design Approach ◽  
Coefficient Of Determination ◽  
Injectable Formulation ◽  
Rp Hplc ◽  
Relative Standard ◽  
Quality By Design Approach

AbstractThe objective of the present study was to develop a robust, simple, economical and sensitive HPLC-UV method using the “quality-by-design” approach for the estimation of irinotecan (IRI) in marketed formulations. RP-HPLC method was developed by applying Box-Behnken design with Hyper-Clone (Phenomenex®) C18 column (250 × 4.6 mm id, particle size 5 µm, ODS 130 Å) as a stationary phase. Acetonitrile and 20 mmol L−1 potassium phosphate buffer (pH 2.5) containing 0.1 % triethylamine in a ratio of 45:55 % (V/V) was used as a mobile phase. The sample was injected in a volume of 20 µL into the HPLC system. UV detector at 254 nm was used to estimate and quantify IRI. Isocratic elution was opted while the flow rate was maintained at 0.75 mL min−1. The retention time of IRI was found to be 4.09 min. The responses were found to be linear for concentration range of 0.5 to 18.0 µg mL−1 and the coefficient of determination value was found to be 0.9993. Percent relative standard deviation for intra- and inter-day precisions was found in the range of 0.1 to 0.4 %. LOD and LOQ values were found to be 4.87 and 14.75 ng mL−1, resp. Robustness studies confirmed that the developed method is robust with RSD of a maximum 0.1 %. The method is simple, precise, sensitive, robust and economical making it applicable to the estimation of IRI in an injectable formulation.

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.

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.

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