The objective of present study was to develop and validate forced degradation studies to generate reliable and accurate data regardless of whether it is for acceptance, release, stability or pharmacokinetic study. Tramadol hydrochloride is a centrally acting synthetic opioid analgesic binding to specific opioid receptors. Tramadol HCl was freely soluble in methanol and practically soluble in water, sodium hydroxide and hydrochloric acid. The developed method was validated for linearity, LOD and LOQ as per ICH guidelines. Distilled water was chosen as a solvent. The drug has maximum absorbance at 271 nm. Tramdol HCl found to be linear within the concentration range of 30-180 μg/ml with regression coefficient of 0.9903. LOD and LOQ values of tramadol HCl were found to be 3.20 μg/ml and 9.71 μg/ml respectively. Forced degradation of the bulk sample was conducted an accordance with the ICH guidelines. Acidic, basic, hydrolytic and oxidative degradation were used to assess the stability indicating power of the method. The method was fast and economical and it was also selective and sensitive for the desirable range.
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