{"id":785,"date":"2023-01-15T13:04:00","date_gmt":"2023-01-15T13:04:00","guid":{"rendered":"https:\/\/anchrom.in\/blogs\/?p=785"},"modified":"2023-03-03T11:23:03","modified_gmt":"2023-03-03T11:23:03","slug":"how-to-perform-reverse-engineering-in-pharmaceuticals","status":"publish","type":"post","link":"https:\/\/anchrom.in\/blogs\/how-to-perform-reverse-engineering-in-pharmaceuticals\/","title":{"rendered":"How HPTLC is useful for Reverse Engineering?"},"content":{"rendered":"\n

How to Perform Reverse Engineering in Pharmaceuticals?<\/strong><\/p>\n\n\n\n

Reverse engineering\/deformulation is a complex process consisting of several phases, such as the identification and quantification of formulation components. It is used at the beginning of the development of a generic drug product. <\/p>\n\n\n\n

It is generally performed on an innovator’s formulation. This is performed at the laboratory level for the identification, quantification and characterization of API and excipients used.<\/p>\n\n\n\n

This can be performed by using various analytical techniques. From the information obtained after doing analysis, one will get a fair idea about how to formulate a product.<\/p>\n\n\n\n

Reverse engineering is a method that is used to reproduce and redesign an existing product. By using different methods, the design of the product can be studied and the product can be improved.<\/p>\n\n\n\n

How HPTLC is useful for Reverse Engineering?<\/strong><\/p>\n\n\n\n

C<\/strong><\/a>amag HPTLC in pharmaceutical analysis<\/strong><\/a> is one of the effective techniques for various pharma-related analysis. High-performance Thin Layer chromatography is a modern version of TLC wherein the principles are the same but the practice is fully automated and GLP\/USP\/EP compliant.<\/p>\n\n\n\n

HPTLC has the latest generation equipment with USP-compliant software. It is 21CFR Rule 11 compliant and designed for rapid analysis, and more output at a reduced cost.<\/p>\n\n\n\n

Unique features of HPTLC are that it is the fastest, simplest, most economical and flexible, \u201cvisible\u201d technique which can analyse in parallel more than 100 samples. It is risk-free and multiple detections can be made without repeating chromatography.<\/p>\n\n\n\n

HPTLC is used for the analysis of non-volatile organics such as pharmaceuticals, APIs, and botanicals including AYUSH samples, forensics, foods, speciality chemicals, etc. for establishing purity, impurities, fingerprint, identification, quantification and reverse engineering.<\/p>\n\n\n\n

After doing a single analysis, the analyst gets many data points. Data is obtained at 254nm, 366nm, in white light and after derivatization in white light or at 366nm with a suitable TLC photo documentation unit. Chromatograms can be derived along with spectral evaluation by the scanner. The scanner is used for qualitative and quantitative analysis.<\/p>\n\n\n\n

Applications of HPTLC in drug analysis:<\/strong><\/p>\n\n\n\n