Abstract

DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHODS FOR SIMULTANEOUS ESTIMATION OF DICLOFENAC SODIUM AND SERRATIOPEPTIDASE IN PHARMACEUTICAL DOSAGE FORM

*Roshani A. Patel, Smita H. Joshi

ABSTRACT

Two simple, accurate, rapid and precise UV Spectrophotometric methods have been developed for simultaneous estimation of Diclofenac sodium and Serratiopeptidase in combined tablet formulation. Diclofenac sodium and Serratiopeptidase at their respective λmax 272.40 nm and 275 nm shows linearity in a concentration range of 7 – 35 μg/ml and 100 – 500 μg/ml respectively. The methods employed were (A) Q – Absorbance ratio and (B) Area under curve (AUC). Method – A involves measurement of absorbance at 242.20 nm (iso-absorptive point) and 272.40 nm (λmax of Diclofenac sodium). Method – B involves measurement of area at two wavelength range 258.0 – 268.0 nm and 280.0 – 290.0 nm. In both methods linearity for detector response for Diclofenac sodium and Serratiopeptidase were found over the concentration range of 7 – 35 μg/ml and 100 – 500 μg/ml respectively. Both the methods were found to be rapid, specific, precise and accurate can be successfully applied for routine analysis of Diclofenac sodium and Serratiopeptidase in bulk and combined dosage form without any interference by the excipients. The method was validated according to ICH guidelines.

Keywords: Diclofenac sodium, Serratiopeptidase, Q- Absorbance ratio method, Area under curve method.