Pharmaceutical applications of HPTLC and method validation

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