SIMULTANEOUS ESTIMATION OF DICLOFENAC POTASSIUM AND METAXALONE IN BULK AND COMBINED TABLET DOSAGE FORM USING RP–HPLC METHOD

VELURI SVS NAGESWARA RAO; V.V. RAO

Volume : VIII, Issue : I, January - 2018

SIMULTANEOUS ESTIMATION OF DICLOFENAC POTASSIUM AND METAXALONE IN BULK AND COMBINED TABLET DOSAGE FORM USING RP–HPLC METHOD

Veluri Svs Nageswara Rao, V. V. Rao

Abstract :

A simple, precise and accurate isocratic RP–HPLC stability–indicating assay Method has been developed to determine Diclofenac potassium and Metaxalone in their combined dosage forms. Isocratic separation was achieved on a Phenomenex Luna C18 (250 mm × 4.6 mm i.d., particle size 5 µm) column at room temperature in isocratic mode, the mobile phase consists of Acetonitrile: Phosphate Buffer (40:60% v/v) at a flow rate of 1.2 ml/min, the injection volume was 20 μl and UV detection was carried out at 220 nm. The drug was subjected to acid and alkali hydrolysis, oxidation, photolysis and heat as stress conditions. The Method was validated for specificity, linearity, precision, accuracy, robustness and system suitability. The Method was linear in the drug concentration range of 2–64 μg/ml and 8–256 μg/ml for Diclofenac potassium and Metaxalone, respectively. The precision (RSD) of six samples was 1.03 and 0.67% for repeatability, and the intermediate precision (RSD) among six sample preparation was 0.97 and 0.53% for Diclofenac potassium and Metaxalone, respectively. The mean recoveries were between 99.78–99.92% and 99.99–100.11% for Diclofenac potassium and Metaxalone respectively. The proposed Method can be used successfully for routine analysis of the drug in bulk and combined pharmaceutical dosage forms.