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.
[Full Text Article]
[Download Certificate]
Impact Factor : 8.181 
