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THE ICH GUIDANCE PRESCRIBED: STRESSED DEGRADATION STUDY OF PARACETAMOL AND DEVELOPMENT OF A VALIDATED METHOD BY UV SPECTROPHOTOMETRY IN BULK AND PHARMACEUTICAL DOSAGE FORM

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Abstract (2. Language): 
A simple, accurate, precise and cost effective UV-Visible spectrophotometric method have been developed and validated for the estimation of paracetamol in bulk and pharmaceutical dosage forms and extended towards investigating stress degradation behavior by exposing it to variety of forced degradation conditions recommended by ICH. Degradation was moderate in acidic (25 %- 37 %) and alkaline conditions (23 %-26 %). Complete under oxidative stress while 3.3 % in the thermal conditions; however it stable upon neutral and photolytic exposure. The method was specific to paracetamol and also selective to its degradation products. The proposed method is suitable for quality control of formulation without interference of the excipients
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Available Online at www.ijprbs.com
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