Optimization of HPLC-FLD Conditions Using Analytical Quality by Design Approach for Quantification of Silodosin in Pharmaceutical Dosage Form

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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A stability-indicating method for Levetiracetam in tablets using advanced analytical quality-by-design approach ‎

Journal Of Advanced Pharmacy Education And Research ◽

10.51847/dwtvdvjkwj ◽

2021 ◽

Vol 11 (3) ◽

pp. 126-131

Author(s):

Maher Abdulrazzaq Al-hakeem ◽

Lacramioara Popa ◽

Cristina Dinu-Pirvu ◽

Mihaela Violeta Ghica ◽

Razvan Prisada

Keyword(s):

Quality By Design ◽

Design Approach ◽

Analytical Quality ◽

Stability Indicating ◽

Stability Indicating Method ◽

Quality By Design Approach

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Analytical quality by design approach in RP-HPLC method development for the assay of etofenamate in dosage forms

Indian Journal of Pharmaceutical Sciences ◽

10.4103/0250-474x.174971 ◽

2015 ◽

Vol 77 (6) ◽

pp. 751 ◽

Cited By ~ 6

Author(s):

R Peraman ◽

K Bhadraya ◽

YPadmanabha reddy ◽

CSurayaprakash reddy ◽

T Lokesh

Keyword(s):

Method Development ◽

Quality By Design ◽

Dosage Forms ◽

Hplc Method ◽

Design Approach ◽

Analytical Quality ◽

Rp Hplc ◽

Quality By Design Approach ◽

Hplc Method Development

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Analytical Quality by Design Approach for Development of a Validated Bioanalytical UPLC Method of Docetaxel Trihydrate

Current Pharmaceutical Analysis ◽

10.2174/1573412911666150121234150 ◽

2015 ◽

Vol 11 (3) ◽

pp. 180-192 ◽

Cited By ~ 10

Author(s):

Rajneet K. Khurana ◽

Sarwar Beg ◽

Devi Lal ◽

O. P. Katare ◽

Bhupinder Singh

Keyword(s):

Quality By Design ◽

Design Approach ◽

Analytical Quality ◽

Quality By Design Approach

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

International Journal of Pharmaceutical Sciences and Nanotechnology ◽

10.37285/ijpsn.2018.11.5.4 ◽

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.

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