Introduction:

Preparative liquid chromatography system has been an integral part of pharmaceutical analysis. With more and more challenging structures discovered; the industry is coming up with novel preparatory columns/reagents for purification of highly polar/non-polar/ionizable compounds.

In the fast-paced pharmaceutical market involving APIs, drug products, impurities and excipients, etc the need for prompt structure elucidation is vital to the product release. Simson pharma possess the necessary infrastructure and skill set to achieve the total structure confirmation in minimal time. Impurities stable at only -20 °C are also, after synthesis; separated, isolated and dispatched under the required cooling conditions.

Further; DAC (Dynamic axial compression) columns are used effectively at Simson pharma. Because of the DAC columns, rapid isolation to gram/kilogram scale is feasible in minimal time. For this; the extensive method development is taken up on semi-prep column to effectively separate and achieve optimal resolution of impurities under consideration and subsequently the method is transferred to DAC column using PREP HPLC setting. Higher throughput in minimal time and minimal solvent usage is imperative for the success of any isolation proposed using PREP HPLC.

Now that optimal separation is achieved; the unwanted solvents, buffers, water, etc need to be removed from pure compound. Care is taken for temperature sensitive impurities by keeping them in cooling condition using dry-ice/solvent mixture followed by effective lyophilization process. After this process, the purity of the compounds is of critical importance. We, at Simson pharma, ensure that the compounds are pure by injecting in methods in concerned monograph methods and if monograph method is not available, then in-house methods are being utilized. Many challenging and critical separations have been till date achieved at Simson pharma, thus creating a library of impurities in wide array of therapeutic areas.

Conclusion:

Preparatory chromatography is used when we are unable to get requisite purity from gravitational columns/flash chromatography. PREP columns, like analytical columns have identical pore size and micron size, except the length and diameter of column is significantly more. As a result, using high pressure technology which PREP HPLC system has to offer, we can get desired separation and subsequently scalability in minimal time. It has since years become a cohesive force and unalienable part of any chemical/pharmaceutical industry.