EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

An International Peer Reviewed Journal for Pharmaceutical, Medical & Biological Sciences

An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)

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 ISSN 2394-3211

Impact Factor: 6.222

 ICV - 79.57

Abstract

CHROMATOGRAPHIC DEVELOPMENT & VALIDATION OF 2-CHLOROMETHYL-4-METHYL QUINAZOLINE FOR QUANTIFICATION OF QUALITY

Dipra Dastider*, Dr. Sudip Kumar Mandal and Dr. Dhrubo Jyoti Sen

ABSTRACT

Linagliptin is a DPP‒4 inhibitor[dipeptidyl peptidase‒4 inhibitor] used as antidiabetic drug which is made of three subordinate units (4‒methyl quinazoline, purine‒2,6‒dione and 3R‒piperidine‒3‒amine) which has one chiral point [8‒[(3R)‒3‒Aminopiperidin‒1‒yl]‒7‒(but‒2‒yn‒1‒yl)‒3‒methyl‒1‒[(4‒methylquinazolin‒2‒yl)methyl]‒3,7‒dihydro‒1H‒purine‒2,6‒dione] at amino piperidine unit. The quality of starting material 2‒(chloromethyl)‒4‒methylquinazoline has been examined for purity to avoid the unwanted impurities, safety and efficacy by which the active pharmaceutical ingredient (API) linagliptin has to be synthesized. A host of impurities in pharmaceutical ingredients do occur that may be partially responsible for toxicity, chemical interference and general instability. In order to ensure that drugs reaching consumers are effective, safe of good quality regulatory requirement now demand to use standard pure API. Purity of API depends on the synthetic process involving chemical reactions using different reagents under different conditions. Therefore, estimation of purity along with impurity profile is necessary to get the pure API. These can only be achieved by thorough analysis of the precursor (Starting Material) used. Here, the anti‒diabetic drug, linagliptin is to be synthesized from 2‒(chloromethyl)‒4‒methyl quinazoline (CMQ). Its standardization i.e. purity and impurity profile has been developed and validated as required by the regulatory authorities. There is no such existing literature reports available for the estimation of CMQ.A key component of the quality of pharmaceutical drugs is the control of impurities. The pharmaceutical analytical chemistry is concerned with new analytical techniques. The main objective of our research work is to develop a RP‒HPLC validated method for estimation of the purity of CMQ (KSM) along with the impurities level (known & unknown). Here, linagliptin (API) has the structural similarity with CMQ (2‒chloromethyl‒4‒methyl‒quinazoline). The method has been developed & validated should have the related impurities level <0.1% (unknown impurities) and <0.15% (known impurities) as per ICHguidelines6,27. This has been carried out in two steps:1.RP‒HPLC Method Development.2.RP‒HPLC Method Validation.

Keywords: CMQ, Linagliptin, API, TLC, UV, RP?HPLC, Rf, Rt, Validation, LOD, LOQ, Robustness, Accuracy, Stability.


[Full Text Article]

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Google Scholar Indian Science Publications InfoBase Index (In Process) SOCOLAR, China Research Bible, Fuchu, Tokyo. JAPAN International Society for Research activity (ISRA) Scientific Indexing Services (SIS) Polish Scholarly Bibliography Global Impact Factor (GIF) (Under Process) Universal Impact Factor International Scientific Indexing (ISI), UAE Index Copernicus CAS (A Division of American Chemical Society) USA (Under Process) Directory of Open Access Journal (DOAJ, Sweden, in process) UDLedge Science Citation Index CiteFactor Directory Of Research Journal Indexing (DRJI) Indian citation Index (ICI) Journal Index (JI, Under Process) Directory of abstract indexing for Journals (DAIJ) Open Access Journals (Under Process) Impact Factor Services For International Journals (IFSIJ) Cosmos Impact Factor Jour Informatics (Under Process) Eurasian Scientific Journal Index (ESJI) International Innovative Journal Impact Factor (IIJIF) Science Library Index, Dubai, United Arab Emirates Pubmed Database [NLM ID: 101669306] (Under Process) IP Indexing (IP Value 2.40) Web of Science Group (Under Process) Directory of Research Journals Indexing