Akshay Charegaonkar, Director, Anchrom Enterprises India, in an interaction with Express Pharma, talks about HPTLC and its benefits
What is HPTLC?
The full form of HPTLC is High Performance Thin Layer Chromatography. It’s an instrumental version of Thin Layer Chromatography which is in practice since 1950s and is used for chemical analysis.
What is unique about HPTLC?
HPTLC produces photographs co-relating to the chemical composition of organic samples. So it is the only ‘visible chromatography.’ It accounts for 100 per cent of the sample, a requirement of cGLP. The results can be evaluated even by a layman. HPTLC analyses dozens of samples simultaneously, quickly and at a low cost. There are numerous other unique features.
Why is HPTLC in news today?
HPTLC has now been declared the official US and European technique for most fundamental test of identification of materials of botanical origin by using HPTLC fingerprint. The Chinese also use the same. HPTLC is also connected to MS.
What is HPTLC fingerprint?
It is (for now) photographic image(s) representing the phytochemical composition of samples, mainly those of botanical origin. One sample can produce several different ‘fingerprints’ after derivatisation. The images are recorded in ultraviolet light at 254 or 366 nanometers or in day light.
Why not use the more popular HPLC technique?
HPLC is best used for pure and ‘clean samples which botanicals cannot. The westerners believe in ‘markers’ i.e. the presence and minimum quantity of certain unknown components. Here HPLC or HPTLC can be used.
What is the difference between TLC and HPTLC?
Today all analysis has to be cGLP compliant. TLC being a purely manual technique fails this criterion. Moreover, in TLC, most parameters are not specified and hence results are unreliable. USP-DSC chapter 203 for the first time ever defines the SOP for HPTLC. The same has been adopted by the Europeans, albeit worded differently. Each and every factor affecting the HPTLC result is controlled in HPTLC. India believes in harmonising with the world’s best quality control practices.
India has already adopted the ‘TLC fingerprint’ for identification. How is the US standard operating procedure (SOP) different?
The India TLC method is good but it has the limitations of non-cGLP and manual nature. The new SOP has a built in system suitability test, HPTLC pre-coated plates are used, application pattern is defined, chromatography is done at 33 per cent relative humidity after 20-minute saturation etc. Basically, each variable is minimised or eliminated.
How will the HPTLC identification test affect India?
A lot of Indian analysts think that USP has no role in their work. This is not true where the world is flat. Firstly, the USP regulations cover not only drugs but herbals, botanicals, dietary supplements and ingredients, neutraceuticals etc. According to the Food Safety Modernization Act 2011 of USA, US FDA inspectors must inspect foreign food suppliers and check for regulatory compliance. In India, where giant pharma companies with deep pockets, experience and expertise have failed to convince the US FDA, what chance does the food exporters e.g: spices exporters have of compliance. Compliance with latest requirements will help export Indian products at premium prices all over the world.
What do you see as the future of HPTLC fingerprint?
It will be on the label of foods, herbal medicines, phyto pharmaceuticals etc., because customers want genuine products and HPTLC fingerprints guarantee that.
EP News Bureau – Mumbai