Herbal medicines are being popularly used by large populations around the world due to their long therapeutic history. At the same time, issues of quality assurance and quality control are hampering its wider acceptance. Due to the very nature of their composition, where a number of active ingredients in different combinations determine the overall efficacy, establishing standards of quality control for raw materials and bringing about standardization of finished product poses a big challenge.

Chromatography- A Potent Tool

Earlier traditional methods based on foreign matter content, microscopical properties and newer yet simpler approaches such as heavy metal analysis method for analysis of heavy metals content or others to detect the presence of microbial contaminants, pesticide content or radioactive contaminant were used to assess the authenticity and quality of complex herbal medicines. Thus, there were only a few markers available to evaluate the herbal drugs. In recent times, innovative methods are being developed for quality evaluation of herbal drugs and one of the most well-known one used in all clinical research organizations is Fingerprint analysis approach using Chromatography. Various methods in this context have been introduced by which the myriad compounds present in complex matrices which give the therapeutic effect in herbal drugs can be assessed for quality. These chromatographic techniques are used in several analytical labs such as liquid chromatography laboratories and column chromatography laboratories.

HPLC- Popular Chromatography Technique

HPLC is one of the most widely used methods other than gas chromatography analysis for analyzing a large amount of compounds in herbal drugs. It is useful for herbal drugs standardization, structural confirmations and purification of compounds. HPLC analysis with reversed-phase columns is being popularly used for analytical separation of herbal drugs. Various factors such as pump pressures, pH adjustment of mobile phases and their differing compositions affect the optimal separation condition for this technique. Hence, it is necessary to have a good experimental design for obtaining an optimal separation.

This method helps to ascertain the partial components in herbs and also quantify their concentrations. The versatility of this method for analysis of chemical compounds in herbal drugs makes it a vital method in assessing quality factor of herbal drugs. However, there is increased use of Evaporative Light Scattering Detection method in combination with this technique which helps in the analysis of non-chromophoric compounds.

CRO Clinical Trials

In the context of herbal medicine too, clinical trials have to be conducted to understand the efficacy of the herbal treatments. India is one of the most preferred destinations to conduct such trials due to the availability of a large and diverse patient pool and high cost savings. Various contract research organizations have been established to carry out such clinical trials in India. There are series of trial phases through which the new medicines have to go to determine if they are safe and effective on human patients. Phase 1 clinical trials use a small sample to test the safety of the new medicine and these go on to Phase 4. However, a balance between patient safety and medical progress has to be ensured during such trials and regulatory bodies have to ascertain that this balance is maintained.