Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF DICLOFENAC SODIUM AND METHYL SALICYLATE IN NANO GEL

Dhaval B. Patel*, Ankit B. Chaudhary, Vijay P. Jodhani.

ABSTRACT

A specific, precise and accurate stability indicating RP-HPLC method was developed for the separation and quantification of Diclofenac Sodium and Methyl Salicylate in pharmaceutical dosage form. The quantification was carried out using C18 column (250 x 4.6mm, 5μm) and mobile phase comprised of Acetonitrile and 0.05M NaH2PO4, pH 2.50 (± 0.05) adjusted with diluted OPA in proportion of ratio 50:50 degassed under ultra-sonication. The flow rate was adjusted to 1.50 mL/min and the effluent was monitored at 281 nm using PDA detector. The retention time of Diclofenac Sodium and Methyl Salicylate were about 4.000 min and 7.300 min respectively. The method was validated in terms of linearity, specificity, precision, accuracy, limit of detection and limit of quantization. Linearity of Diclofenac Sodium and Methyl Salicylate were in the range of 20 – 100 μg/mL and 300 – 1500 μg/mL respectively. The percentage recoveries of both the drugs were found to be 100.22% ± 0.53 and 99.68% ± 0.46 for Diclofenac Sodium and Methyl Salicylate respectively from the gel formulation. The method was found to be precise, accurate and specific during the study. The proposed method enables rapid quantification and simultaneous analysis of both drugs from commercial formulations without any excipients interference. The method can be used for routine analysis of marketed products of Diclofenac Sodium and Methyl Salicylate in combined gel formulation.

Keywords: Diclofenac Sodium, Gel, Methyl Salicylate, RP-HPLC.