DEVELOPMENT AND VALIDATION OF NEW SIMPLE, SENSITIVE AND VALIDATED UV-SPECTROPHOTOMETRIC AND RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF PARACETAMOL AND ETODOLAC IN MARKETED FORMULATION

Ameen Shaikh, Gurdeep Singh, Neetesh K Jain, M K Gupta

Abstract


A simple, precise and highly selective analytical method was developed for simultaneous estimation of Paracetamol and Etodolac in tablet formulation. Estimation was carried out by multicomponent mode of analysis at selected wavelength of 256 and 286 nm for Paracetamol (PCM) and Etodolac (ETD) respectively in methanol: water (60:40). The method was validated in terms of linearity, accuracy (% Recovery), Precision (Interday, intraday, and reproducibility) and robustness. Both methods were linear (R2 = 0.997- 0.999 for UV method and 0.998 for RPLC method) and accurate (% recovery was 98.39-101.17%). The method was also obtained precise (% RSD <2 %) and robust. The linearity was obtained in the concentration ranges of 5.25 μg/ml for paracetamol and 3-16 μg/ml for Etodolac. The method was validated as per international conference of Harmonization (ICH) guidelines.

Keywords: Paracetamol, Etodolac, UV, RP-HPLC, ICH

 


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