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METHOD DEVELOPMENT AND STATISTICAL VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF TOLPERISONE HYDROCHLORIDE AND PARACETAMOL IN SYNTHETIC MIXTURE AND COMBINED DOSAGE FORM

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Abstract (2. Language): 
A simple, novel, sensitive, precise and specific validated spectrophotometric method was developed for simultaneous determination of Tolperisone Hydrochloride (TOL) and Paracetamol (PCM) in synthic mixture and its dosage form using first order derivative spectroscopic method. Methanol was selecte d as a common solvent for estimation of Tolperisone Hydrochloride and Paracetamol with A,max at 254 nm and 248nm respectively in methanol. Linearity was obeyed in concentration ranges of 1-70 |ug/ml for TOL and 1-80 ^g/ml for PCM respectively and calibration curve taken in the concentration range of 3-18 ^g/ml for TOL and 2-12 ^g/ml for PCM. The Zero Crossing Point (ZCP) of TOL was 254.6 nm and PCM was 248.56 nm. The detection limit and quantification limit were found to be 0.299 and 0.908 ^g/ml for TOL and 0.244 and 0.741 ^g/ml for PCM respectively. The method was validated as per the International Conference on Harmonization (ICH) guidelines. The proposed validated method was successfully used for the quantitative analysis of commercially available dosage form.

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