PHARMACEUTICAL APPLICATIONS OF HPTLC AND METHOD VALIDATION

 HPTLC as an analytical technique has applications in multiple fields. It can be used for qualification and quantification of samples in sectors like Pharmaceuticals, Herbals, Cosmetic, Food and Forensic sciences and it can also be used as a fingerprint analysis technique in the above fields. HPTLC instrumentation involves different modules for application, development, image documentation and detection.

Application of HPTLC in pharmaceutical field: As all the compounds which are analysed by TLC can be analysed using HPTLC, it has a wide variety of applications in the Pharmaceutical field.

1.       Impurity profiling

2.       Content Uniformity

3.       Forced Degradation

4.       Stability

5.       Limit test

6.       Assay

Validation of a method is very important as it tests the suitability of the method and makes sure that there are no errors. HPTLC Analysis Analytical method validation is essential in the Pharmaceutical field and the ICH Q2 guidelines speak in detail regarding the types of analytical procedures that need to be validated, viz.:

1.       Identification tests

2.       Quantitative tests for impurities content

3.       Limit test for the control of impurities

4.       Quantitative tests for the active moiety in samples of drug substance or drug product or other selected components in the drug product

It is also important to understand the objective of the analytical procedure based on which the validation characteristics will be evaluated.

One such example of validation done using CAMAG HPTLC is that of Cyclobenzaprine HCl, which is a skeletal muscle relaxant used to treat muscle spasms, strains, sprains and other muscle injuries.

The analytical method was developed and validated for linearity, robustness & ruggedness, specificity, LOD & LOQ and the following results were obtained:

·         Linearity: 4.826 mg Cyclobenzaprine HCl in the given sample of tablet

·         Recovery: 98%

·         LOD: 160.60 Nano grams

·         LOQ: 486.69 Nano grams

Comments

Post a Comment

Popular posts from this blog

How do You Test for Colorless Substances in Chromatography?

Image
  How Do You Test For Colorless Substances In Chromatography? by  Anchrom Lab   Thin Layer Chromatography/High Performance Thin Layer Chromatography is suitable for detection of organic and nonvolatile compounds. There are many compounds which do not have chromophoric group therefore we can not see them with naked eyes. Sometimes these compounds have UV/fluorescence. Such compounds can be detected by using suitable instrument like UV cabinet or CAMAG visualizer which can detect compounds in short UV i.e., 254nm, long UV i.e., 366nm and white light or if any compound is not UV active, a technique of derivatization can be used to make them visible. UV detection, spectra and derivatization are powerful tools which helps in detection of colorless substances in  High Performance Thin Layer Chromatography technique. How colorless substances are analyzed by HPTLC? HPTLC is a stepwise technique. One has to follow certain sequence while doing analysis. First step is application of sample on sui
Read more

Factors Affecting Resolution in Chromatography

Image
  As we all know, Chromatography is a science of separation of mixtures into its components. There are several types of chromatography, each differing in the kind of stationary phase and mobile phase they use. There are many chromatographic techniques like HPLC, HPTLC and GC. Let us understand what is the resolution in Thin Layer Chromatography? Many times we use the term ‘Resolution’ but what exactly does it mean in TLC/HPTLC?      In Chromatography resolution is ability (of the method) to separate two peaks. In Thin Layer Chromatography or  High-Performance Thin Layer Chromatography , as it is a visual technique, we can also say it is the ability of the method to separate two bands or two peaks. Resolution is termed good when there is a difference of Rf 0.05 between two bands. Ideal resolution is considered when there is base to base separation between adjacent bands. What are the factors affecting resolution in high performance thin layer chromatography? HPTLC is modern version of T
Read more

Automate Your Analytical Processes with the Continuous Flow Analyzer

Image
  Automatic Continuous Flow Wet Chemistry Analyzer In the world of analytical chemistry, efficiency and reliability are paramount. Laboratories dealing with various sample matrices, such as sea water, drinking water, wastewater, environmental samples, soil, food, beverages, tobacco, and more, face the challenge of testing different parameters accurately and efficiently. Manual sample preparation methods can be complex and time-consuming. However, a revolutionary solution has emerged— the AMS Alliance FUTURA 3 Continuous Flow Analyzer. This cutting-edge instrument automates the testing process, providing a complete and reliable solution for laboratories seeking streamlined operations. Each FUTURA 3 console integrates a high precision 3-speed peristaltic pump (medium, fast (startup and washout more speed) and slow (for low consumption of reagents)), a removable drawer for reagents, an analytical manifold, a heater, a detector, and a built-in display for the presentation of essential diag
Read more