A REVIEW ON THE DEVELOPMENT AND VALIDATION OF NOVEL ANALYTICAL METHODS USING THE RP-HPLC METHOD

Srishti Katiyar*, Harshita Gupta, Garima Verma, Prashant Kumar Katiyar, Deepak Katiyar and Rammurat Yadav

ABSTRACT

Any product or service needs analysis, and drugs are no different because they involve human life.[1] Analytical chemistry is the study of the separation, measurement, and chemical additive identification of synthetic and natural materials made up of one or more compounds or elements. The two main categories of analytical chemistry are qualitative evaluation and quantitative evaluation. The former involves identifying the chemical additives present in the sample and the latter calculates the amount of positive detail or compound present in the substance, i.e., the sample.[2] Each year, there is an increase in the amount of medication that is released onto the market. These medications may also be brand-new things or just slight structural changes made to the ones we already have. Medicines should be available in a way that guarantees their quality, bioavailability, adequate plasma concentration, desired timeframe, commencement of action, proper dose, safety, effectiveness, and stability during product storage.[3] The process of improving a drug involves many steps, including drug discovery, research lab testing, preclinical testing, clinical testing, and regulatory registration. Many administrative organisations, such as the United States Food and Drug Administration (USFDA), also mandate that the drug product be evaluated for its identification, potency, characteristics, quality, stability, and purity before it can be released for use in order to further improve the sufficiency and protection of the medication after acceptance. Therefore, it is essential to implement pharmaceutical validation and process controls to avoid any potential problems.[4] A medication's introduction to the market and the date it is taken into consideration for inclusion in pharmacopoeias frequently occur at different times. This is due to potential flaws in the ongoing and extensive use of those pharmaceuticals, claims of ongoing toxicity (leading to their removal from the market), the emergence of patient resistance, and the advancement of more advanced medical treatments in an effort to compete. In some cases, there may be requirements and analytical methods for certain medications that are outside the scope of pharmacopoeias. It becomes required in order to create fresher analytical methods for such drugs.[5] The HPLC method's objectives are to compute all available synthetic intermediaries, the main active drug, any response impurities, and any degradants.[6] The word "chromatography" is derived from the word’s "chromo" and "graphs," which both indicate "to write," so that in the process, colour groups are formed and then measured or examined. The division of different compounds shapes these colour groups.[7] Standards and analytical techniques for certain medications may not be included in the pharmacopoeias under these circumstances. Therefore, the creation of more modern analytical techniques for such drugs is required.[8] The goal of the characterisation is to produce a trustworthy, accurate, and understandable collection of data that describes the sample.[9] Because drugs have a direct impact on human life, analysis is crucial for any good or service.[10]

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