Vorasidenib, a novel dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2), has gained

considerable attention for its therapeutic potential in the treatment of low-grade gliomas and other IDH-mutant

malignancies. Accurate and reliable analytical methods are essential for the quantitative estimation of

Vorasidenib in bulk drug and pharmaceutical dosage forms to ensure quality, safety, and efficacy. Among the

available analytical techniques, Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) has

emerged as the method of choice due to its sensitivity, selectivity, reproducibility, and cost-effectiveness. This

review highlights the development and validation strategies of RP-HPLC methods for Vorasidenib, focusing

on critical parameters such as selection of stationary and mobile phases, optimization of chromatographic

conditions, and detection wavelength. Method validation is discussed in accordance with ICH guidelines,

detection (LOD)

Human life starting from birth to death mostly depends on medicines like vaccines, pharmaceutical dosages,

drugs, vitamin tablets, mineral supplements, energy drinks, boosters etc. The word medicine is drawn from

pharmaceutical sciences were now leading a long span of healthy life. Medicines enhanced the life expectancy

of humans and are considered to be the most important necessity of mankind which plays a vital role in curing

the diseases and health issues. People who are suffering with hypertension, diabetes etc. are completely

depending on the medicines throughout their tenure of life. Thus, the medicine is basically concerned with the

health and welfare of the human2 .

combinations are required. Medicines are there since from the ancient times and most of them are prepared by

using herbals, natural ingredients and by the other home remedy methods. Preparation of the medicines is

mainly concerned with the efficiency of the drug and the existing technology. The medicines should maintain

certain requirements - like purity, effective reaction time, lack of side effects etc.

Pharmaceutical companies look at qualitative and quantitative analysis to verify the quality of final product

and to check that their raw materials meeting their indeed specifications3 . Qualitative analysis concerns with

the identification of elements, functional groups or compounds in a sample, whereas the quantitative analysis

helps in the determination of amount of a particular element, species or compound in the given sample4 ,

which enable us to maintain permissible limits of impurities in the sample.

identification, determination, quantitation and purification of drugs. It is mainly used for the separation of the

components in a mixture and also for the determination of the structure of chemical compounds9 . Analytical

method development for a newly manufactured product is so crucial because the chemical formulation does

not available in any pharmacopoeias. The newly introduced analytical techniques were suggestive in order to

determine the chemical quality standards of the medicine10 .

For the qualitative and quantitative analysis of various drug products the following analytical techniques are

readily available.

Titrimetric analysis implies in the determination of concentration of a standard solution to react quantitatively

electrical quantities such as electric current, voltage or potential, charge and their relationship with the

chemical parameters12 .

Chemical kinetics provides a major tool for the study of chemical mechanisms, and the detailed account of

the rate of a chemical reaction is proportional to the active masses of the reacting substances each raised to the

power of its coefficient in the stoichiometric equation13

The principle of electrophoresis is very simple, namely that a charged ion or group migrates towards one of the

electrodes when placed in an electric field and this technique operates on a principle which is different from

Flow injection analysis and Sequential injection analysis In flow injection analysis (FIA) definite volume of

the liquid sample is injected into a moving, non-segmented continuous carrier stream of a suitable liquid15.

The injected sample forms a zone, which is then moves towards a detector that continuously records the

changes in absorbance, electrode potential, or other physical parameter resulting from the passage of the

sample through the flow cell15 . The flow injection technique is used as an automated solution handling

applications in the analysis of biomaterials, especially natural products21 . Hyphenated analytical methods

provide more compatible information in less time leading to faster and accurate results. Here the combinations

include separationseparation, separation-identification and identification-identification techniques22 .

Chromatography is unique in the history of analytical methodology and is probably the most powerful,

versatile and widespread technique available in the modern chemical analysis. It plays a vital role in the

advancement of chemistry, biology, medicine and the other similar fields of science. It can be used together

with detection systems such as electrochemical, photometric and mass spectrometry due to its simplicity and

ease of operation. Chromatography is extensively used for the separation and identification of complex

chemical mixtures23 . Advanced methods of spectroscopy and chromatography are accelerating the method

Chromatography can be achieved by distributing the chemical components of a mixture through a moving

mobile phase and a stationary phase in which the mobile phase (liquid or a gas) flows through the stationary

phase (solid, or a liquid supported on a solid) and carries the components with it. The components which have

stronger interactions with the stationary phase move slowly than the components having weaker interactions

through the column. This difference in flowrates causes the separation of components in the mixture.

A method is a set of experimental conditions designed to create a good analysis of the given sample. HPLC

method development and validation plays a prominent role in the discovery, development and manufacture of

pharmaceuticals and agro chemical products. Understanding the physical and chemical characteristics of the

drug helps us to select the most appropriate method development. By the method development, information

Literature Survey

Selection of Mode

Selection of detection wavelength

Selection of chromatographic techniques

Selection of chromatographic conditions

Sample injection and Analysis

Method Validation

are considerably effective, which results waste of time, money and the other resources.”

The suitability of a method for its intended purpose can be demonstrated by analytical method validation.

Instruments / Equipment are to be validated and calibrated

Reference Standards and Reagents are to be standardized

Trained and qualified analysts

Availability of Test methods,

glassware's, Specifications etc.

Availability of test material

Approved protocols.

The following parameters are considered for the validation of HPLC method29

Robustness

System Suitability

Sample Solution Stability

27. Palmer, L. S., Carotenoids and Related Pigments, The Chromophlipids, ACS Monograph Series,

American Chemical Society, New York, 316, (1922)

28. http://shodhganga.inflibnet.ac.in/bitstream/10603/110204/8/08_part%20a%20section %201.pd

29. https://www.fda.gov/downloads/Drugs/Guidances/UCM134409.pdf