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Related Concept Videos

Data Validation01:15

Data Validation

183
Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
Key parameters for method validation include:
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High-Performance Liquid Chromatography: Instrumentation00:57

High-Performance Liquid Chromatography: Instrumentation

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High-performance liquid chromatography, or HPLC, is an analytical technique that separates liquid samples under high pressures. An HPLC instrument consists of glass bottles for storing solvents called mobile phase reservoirs. HPLC-grade solvents are used to maintain high purity, and the dissolved gases are removed using a degasser, such as a vacuum pumping system or sparging with helium. The solvents are then pumped into the analytical column using a screw-driven syringe or reciprocating pumps.
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High-Performance Liquid Chromatography: Introduction01:11

High-Performance Liquid Chromatography: Introduction

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High-performance liquid chromatography(HPLC), formerly referred to as High-pressure liquid chromatography, is a powerful technique used to separate, identify, and quantify components in complex mixtures. The term "high pressure" refers to using high pressure to push the liquid mobile phase through the tightly packed columns.
In HPLC, two phases play a critical role in the separation process:
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Analytical Method Development, Validation and Forced Degradation Study of Dapagliflozin by RP-HPLC.

Ujwal Chaudhari1, Jagdish K Sahu1, Payal R Dande1

  • 1School of Pharmacy & Technology Management, SVKM's NMIMS (Deemed to be University), Shirpur, Distt - Dhule (Maharashtra), 425405, India.

Drug Metabolism and Bioanalysis Letters
|August 24, 2023
PubMed
Summary
This summary is machine-generated.

A new stability-indicating HPLC method accurately detects dapagliflozin in API. This validated method demonstrates drug stability under various stress conditions, ensuring reliable analysis for pharmaceutical quality control.

Keywords:
DapagliflozinICH guidelineRP-HPLCT2DManalytical validationdegradation

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Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Sciences

Background:

  • Type 2 diabetes mellitus (T2DM) affects millions globally, with current treatments having limitations.
  • Innovative therapies are needed to manage T2DM effectively.

Purpose of the Study:

  • To develop and validate a stability-indicating high-performance liquid chromatography (HPLC) method for dapagliflozin.
  • To assess the specificity and stability of dapagliflozin using the developed method.

Main Methods:

  • A stability-indicating reverse-phase HPLC (RP-HPLC) method was developed using a Kromasil C18 column and UV detection.
  • Method validation followed International Council for Harmonisation (ICH) guidelines.
  • Stress degradation studies were performed under acidic, alkaline, oxidative, thermal, and photolytic conditions.

Main Results:

  • The HPLC method achieved a retention time of 1.67 minutes with all system suitability parameters within acceptable ranges.
  • Dapagliflozin demonstrated stability under photolytic, thermal, neutral, alkaline, and oxidative stress.
  • The method's validation parameters (linearity, precision, robustness) met ICH Q2 standards.

Conclusions:

  • The developed HPLC method is stability-indicating and specific for dapagliflozin.
  • This validated method can be reliably used for analyzing dapagliflozin in tablet dosage forms.