A brief review on analytical method development and validation for the determination of related substances/impurities on anti-depressant drugs

ABSTRACT:In this review on stability indicating validated analytical method development and validation for the determination of relatedsubstances/impurities on anti-depressant drugs, the drug and/or drug product are analysed for the various impurities vizrelated substances, degradants or process –related impurities. Related substances are one among the impurities. Variouspharmacopeias have established the level of impurities to be present in an API or drug product. But globally InternationalConference on Harmonization (ICH) guidelines Q3A and Q3B – Impurities on new drug substances and new drug productsrespectively are verified and followed. The threshold limits for impurities is usually <0.05%. The shortcomings of variousmentioned techniques with appreciation to regulatory necessities are highlighted. A stability indicating analytical methoddevelopment and validation for determination of related substances/impurities in anti-depressant drugs such as “Duloxetine,Venlafaxine, O-desmethyl venlafaxine, Milnacipran, Bupropion hydrochloride, Fluoxetine” is discussed. This review helpsresearchers to get an idea about stability-indicating methods of development and validation for anti-depressant drugs and theimpurities present in the drug or drug product that might occur during synthesis, intermediate or storage.