Abstract
A STUDY OF DEGRADATIVE EFFECT USING VALIDATED LC-PDA METHOD FOR COMBINED DOSAGE FORM OF PARACETAMOL, TIZANDINE HCL AND ACECLOFENAC

Guganathan, Bharani Pandilla*, Vijayageetha R., Sakthimaan Singh B. and Sathiyasree G.

ABSTRACT

To optimise a sensitive, robust and reliable HPLC technique for quantification of PAR, TZN and ACE in the presence of degradants and validate in accordance with ICH guidelines. Isocratic elution using mobile phase ratio of 0.1mM phosphate buffer pH 7.00:Acetonitrile (65:35) and phenomenex C18 (250 × 4.5 cm, 5µ) column used for chromatographic separation and the solvent delivery was 1.0mL/min and UV detection was programmed at 280 nm for 0-4 mins, 320nm for 4.01-10 mins and 280 nm for 10.01-45 mins. Retention time of PAR, TZN and ACE was 3.8 min, 5.6 min and 12.0 min respectively. The applied HPLC technique showed good linearity across the range of 250-750µg/ml concentration for PAR, 50-150µg/ml for ACE and 0.50-1.50µg/ml for TZN. The recoveries accomplished for PAR, TZN and ACE were 100.12, 99.78, and 100.78 respectively. The three drugs were subjected to acid, alkali, oxidation, sunlight and thermal degradation. The degradation products formed in all stress condition were separated from the principal peaks and the % RSD was found to be less than 2% which indicate that the method is highly specific and had excellent reproducibility. The proposed and validated technique can be efficiently applied for regular analysis of PAR, TZN and ACE in formulation.

Keywords: RP-HPLC, PAR-Paracetamol, TZN-Tizanidine hydrochloride, ACE- Aceclofenac, stability indicating, Validation.


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