High-Performance Thin-Layer Chromatography in the Pharmaceutical Industry: An Essential Analytical Technique

Introduction

In the ever-evolving pharmaceutical industry, the need for accurate and efficient analytical techniques is paramount.

High-Performance Thin-Layer Chromatography (HPTLC) has emerged as a powerful tool for qualitative and quantitative analysis, providing valuable insights into the composition, purity, and stability of pharmaceutical products.

HPTLC has a significant role in the pharmaceutical industry owing to its contributions to drug development, quality control, and regulatory compliance.

Applications of HPTLC in the Pharmaceutical Industry

1.      Drug analysis and quality control:

HPTLC is extensively used for the analysis of drugs and pharmaceutical ingredients.

It enables the separation, identification, and quantification of active pharmaceutical ingredients (APIs) and impurities in drug formulations. It helps ensure the quality, purity, and consistency of pharmaceutical products.

2.      Dissolution testing:

HPTLC can be employed for dissolution testing, which assesses the rate at which an API is released from a pharmaceutical formulation.

By monitoring the dissolution profile, HPTLC assists in evaluating the dissolution behavior of drugs, which is crucial for determining their bio availability and therapeutic efficacy.

3.      Stability studies:

HPTLC plays a significant role in stability studies of pharmaceutical formulations. It enables the detection of degradation products, impurities, and changes in drug content over time, aiding in assessing the shelf life and storage conditions of drugs.

4.      Formulation development:

HPTLC assists in the development of pharmaceutical formulations by providing information on the compatibility, stability, and interactions of different drug components.

It aids in optimizing the formulation composition and determining the appropriate processing conditions.

5.      Bioanalytical studies:

HPTLC can be utilized in bioanalytical studies to determine the concentration of drugs and their metabolites in biological samples such as blood, urine, or tissues.

It is a valuable tool for pharmacokinetic studies, assessing drug absorption, distribution, metabolism, and excretion.

CAMAG HPTLC fulfilling the requirement of Pharmaceutical Industry

The pharmaceutical industry needs to adhere to strict documentation and compliance requirements such as

High Sample Throughput Technique:

HPTLC offers rapid analysis compared to other chromatographic techniques, as it has the ability to analyze multiple samples simultaneously and with minimal sample preparation and less solvent consumption, thus giving high sample throughput and cost-effectiveness.

Documentation:

This includes maintaining detailed records of sample preparation, analysis parameters, instrument calibration, and validation procedures.

The visionCATS operated HPTLC system comes with the features that can document and record all the activity during the analysis.

Compliance:

HPTLC methods can be developed and validated following regulatory guidelines, such as ICH, USP, EP. These methods are specific, sensitive, accurate, and precise and ensure reliable results.

visionCATS supports the following compliance:

● 21 CFR Part 11:

The option 21 CFR Part 11 supports customers to work in a controlled environment and to establish regulatory-compliant processes.

As a part of 21 CFR Part 11 compliance, electronic signature processes, motivated change management, User access controls, A set of log files (System log; Method log; Analysis log; Backup log) , User Management rights are available.

● Qualification:

For customers working in a cGMP/cGLP environment, CAMAG HPTLC offers Installation Qualification (IQ) and Operation Qualification (OQ) services.

● System Suitability Test (SST):

System Suitability Tests are used on each plate to check and ensure that the analysis was performed appropriately to produce results that are within the acceptance criteria established during method development.

Only data from plates qualified by the respective SST can be directly compared. The SST is the primary tool for evaluation of data during a transfer validation. visionCATS provides several tools for setting up a SST.

● Data Security:

Data Security is achieved through access control, which is provided by a flexible, secure, and customizable User Management System and basic system settings. Users are defined with rights that determine the level of access they have.

The User Management System is compatible with Active Directory. With the powerful user management, it is possible to reflect the customers’ individual safety regulations. Data are stored in a safe database to prevent accidental alteration/deletion.

● Data Safety:

The visionCATS Backup Assistant helps users to store their data into a backup file. Automatic backup tasks can be defined with the Schedule Assistant. With the Restore Assistant users can easily restore their data from the backup file.

Client/server system:

visionCATS is based on a client/server system, enabling scalability from a single workstation to a multi-user lab network.

Anchrom Enterprises Pvt. Ltd stands as a leading provider of HPTLC analysis services and state-of-the-art HPTLC chromatography instrumentation for a range of industries, including pharmaceuticals, plant extracts, drugs, cosmetics ingredients, and forensic science.

Our cutting-edge HPTLC instruments enable precise and efficient separation and analysis of compounds in diverse samples. With a focus on high-resolution separation, accurate quantification, and reliable results, our HPTLC chromatography instrumentation empowers researchers and analysts in the pharmaceutical industry and beyond.

For all your HPTLC analysis and instrumentation needs, please don’t hesitate to contact us at lab@anchrom.in for more information.