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  • A Review On Development And Validation Of Ultra Performance Liquid Chromatography For Estimation Of Drug In Pharmaceutical Dosage Form By Quality By Design Qbd Approach
  • 1Department of Pharmaceutical Quality Assurance, R. G. Sapkal Institute of Pharmacy, Anjaneri, Nashik
    2Department of Pharmaceutical Chemistry, R. G. Sapkal Institute of Pharmacy, Anjaneri, Nashik

Abstract

The pharmaceutical business, system optimization, stationary phase vs mobile phase, detector design, data processing, and data integrity control have all seen notable technical advancements in recent years. The individual accomplishments in each subject have led to a step-function increase in technique and performance when technology and quality are combined. A new method of using liquid chromatography for sample detection is provided by ultra-performance liquid chromatography (UPLC). UPLC primarily improves the resolution, speed, and sensitivity of liquid chromatography. UPLC approach uses Quality by Design to improve performance. With the help of a more recent paradigm known as Quality by Design (QbD), the pharmaceutical industry is now able to create durable and reliable medicinal products that consistently meet the predetermined quality standards. The QbD strategy stresses establishing quality from the beginning of research and development and aids in the creation of goods and medicine samples that adhere to consumer and regulatory standards. QbD is already popular and has had incredible success in pharmaceutical formulation in many forms. However, the scientific community has not yet accepted and given genuine significance to the application of QbD in analytical research and development, also known as Analytical Quality by Design (AQbD). Using a strong design space to operate within, AQbD helps to enable the creation of high-quality analytical methods with better method performance that comply with regulatory requirements. This helps to prevent failures during the method transfer process and has a high degree of detection. The goal of the opening review article is to raise general understanding of the UPLC method's development and validation information using Quality by Design (QbD) and associated methodologies in order to evaluate medicinal active substances throughout the last ten years. The essay also concentrated on a broad review of the QbD approach to UPLC technique development. For the identification and assessment of drugs in bulk and pharmaceutical dose form, the UPLC technique was developed and validated using the QbD methodology.

Keywords

Quality by Design, Method development, Validation, Drug, UPLC, HPLC

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Kanchan Shinde
Corresponding author

Department of Pharmaceutical Quality Assurance, R. G. Sapkal Institute of Pharmacy, Anjaneri, Nashik

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Neha Gaikwad
Co-author

Department of Pharmaceutical Quality Assurance, R. G. Sapkal Institute of Pharmacy, Anjaneri, Nashik

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Varsha Pangale
Co-author

Department of Pharmaceutical Quality Assurance, R. G. Sapkal Institute of Pharmacy, Anjaneri, Nashik

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Charushila Bhangale
Co-author

Department of Pharmaceutical Chemistry, R. G. Sapkal Institute of Pharmacy, Anjaneri, Nashik

Kanchan Shinde*, Neha Gaikwad, Varsha Pangale, Charushila Bhangale, A Review On Development And Validation Of Ultra Performance Liquid Chromatography For Estimation Of Drug In Pharmaceutical Dosage Form By Quality By Design (Qbd) Approach, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 7, 123-138. https://doi.org/10.5281/zenodo.8112767

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