Abstract

UV/HPLC SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF DICLOFENAC SODIUM AND SERRATIOPEPTIDASE

Amisha Thakur*, Bhaskar Upmanyu, Mona Piplani, Pankaj Bhateja and Preeti Avasthi

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Abstract

A Simultaneous estimation of UV/RP-HPLC method was developed and validated for the estimation of Diclofenac Sodium and serratiopeptidase in tablet dosage form using C18 column (150 X 4.6mm, 5μ) with mobile phase consisting of orthophosphoric acid and Methanol with a flowrate of 1.0ml/min and Absorption maxima at 260nm. Accuracy of drugs was observed to be within the limits of 97% to 102% by mean of 3 determinations 50%, 100% and 150%. Precision of drugs was observed to be less than 2.0 of %RSD by mean of 6 determinations. Linearity was observed over the concentration range 1- 60 μg/ml (r2 =0.998) with regression equation y = 31265x – 9459.9 for Diclofenac sodium and Serratiopeptidase 1–60 μg/mL (r2 =0.997) with regression equation y = 153.4886x + 3130.8667. LOD and LOQ of Diclofenac Sodium and serratiopeptidase were found to be 0.016μg/ml, 0.048μg/ml, and 0.151μg/ml, 0.46μg/ml respectively. The method was validated as per ICH guidelines.

Keywords: Diclofenac Sodium, Serratiopeptidase, HPLC, UV, Method development, Method validation.