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The International Conference on Harmonization (ICH) guideline entitled "Stability testing of new drug substances and products" requires that stress testing be carried out to elucidate the inherent stability characteristics of the active substance. Acidic, alkaline, oxidative and photolytic stability are required. An ideal stability indicating method is one that quantifies the standard drug alone and also resolves its degradation products. Therefore, it was thought to develop the stability indicating HPLC method for the drug candidate lamivudine by using modern statistical application i.e...