Volume 1 • Issue 4 • 1000120 J Pharma Care Health Sys ISSN: 2376-0419 JPCHS, an open access journal Research Article Open Access Pushpa Kumari et al., J Pharma Care Health Sys 2014, 1:4 DOI: 10.4172/2376-0419.1000120 Research Article Open Access Keywords: Trilisate tablets; Salicylic acid; Reverse – phase HPLC; Validation; Stability indicating method. Introduction TRILISATE [1] is a non-steroidal, anti-infammatory preparation containing Choline magnesium trisalicylate. It is used to relieve the pain, tenderness, infammation and stifness caused by arthritis and painful shoulder. It is also indicated as anti-pyretic and analgesic. Choline magnesium trisalicylate is a non-acetlyated salicylate. It is a combination of choline salicylate and magnesium salicylate. It acts by inhibiting prostaglandin synthesis, and also acts on the hypothalamus heat-regulating centre to reduce fever. Choline magnesium trisalicylate has a molecular formula of C 26 H 29 O 10 NMg, a molecular weight of 539.8, and chemical structure is given in the Figure 1. Literature survey revealed that only few methods [2] are available for the estimation of Choline magnesium trisalicylate in pharmaceutical dosage forms. Te aim of the present study was to develop a simple, economical, accurate and stable analytical method for the estimation of Salicylic acid in pharmaceutical dosage form and to validate the method according to ICH guidelines. Experimental Methods HPLC instrumentation and conditions Chromatographic separation was achieved by using an Agilent Model 1100 series HPLC, with a 20 µl sample injection loop (automatic), and UV-Visible absorbance detector and photo-diode array detector. Te output signal was monitored and integrated using Chemistation sofware. Xorabax XBD C18 (150 × 4.6 mm, packed with 5 µm) column was used for the separation. Chemicals and reagents Methanol and Acetonitrile of HPLC grade were purchased from E.Merck (India) Ltd., Mumbai. Dihydrogen potassium phosphate and phosphoric acid of AR grade were obtained from Qualigens Fine Chemicals Ltd., Mumbai. Salicylic acid is available as Trilisate ® with label claim of 500, 750 and 1000 mg of drug. Chromatographic conditions Te mobile phase consisting of bufer, methanol was fltered through 0.45 µ membrane flter before use, degassed and were pumped from the solvent reservoir in the ratio of 80:20 v/v into the column (C18) at a fow rate of 1 ml/min. Te detection was monitored at 230 nm and the runtime was 8 min. Preparation of the mobile phase Preparation of mobile phase: Mobile phase was prepared by mixing the 0.05M phosphate bufer (pH 3.0) and methanol in the ratio of 80:20 v/v. Te solution was fltered through a 0.45 µm membrane flter and degassed before use. Mobile phase is used as a diluent. Preparation of standard stock and working standard solution: Salicylic acid Stock solution (200 µg/ml) was prepared by accurately weighing 20 mg of Salicylic acid in a 100 ml volumetric fask and making up to volume with mobile phase. Working standard solution (20 µg/ml) for HPLC was prepared by diluting 5ml of standard stock solution to 50 ml with mobile phase. Solutions were fltered through a 0.45 µm membrane flter prior to injection. *Corresponding author: Pushpa Kumari K, Research Scholar, Pharmaceutical Analysis, University College of Pharmaceutical Sciences, Andhra University,Vishak apatnam-530003, India, Tel: 7702927897; E-mail: pushpa.pharma007@gmail.com Received October 15 2014; Accepted November 17, 2014; Published November 20, 2014 Citation: Kumari KP, Sankar G, Sowjanya P, Madhubabu S (2014) Stability Indicating RP-HPLC method Development and Validation of Salicylic Acid in Choline Magnesium Trisalicilate (Trilisate) Tablets. J Pharma Care Health Sys 1: 120. doi:10.4172/2376-0419.1000120 Copyright: © 2014 Kumari KP, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Abstract A stability indicating RP-HPLC method was developed and validated for the determination of Salicylic acid in Trilisate tablets using Xorabax XBD C18 column (150 × 4.6 mm, 5 µm) with mobile phase consisting of Phosphate buffer (pH 3.0), methanol (80:20 v/v) with a fow rate of 1ml/min. Detection was carried out at 230 nm. Retention time was found to be 4.6 min. Linearity was observed over the concentration range of 5-30 µg/ml (R 2 =0.999) with regression equation y=30.55x+5.302. Salicylic acid was subjected to stress conditions including acidic, alkaline, photolysis and thermal degradation. The drug is more sensitive towards alkaline degradation. The method was validated as per ICH guidelines. Stability Indicating RP-HPLC method Development and Validation of Salicylic Acid in Choline Magnesium Trisalicilate (Trilisate) Tablets Pushpa Kumari K 1 *, Gowri Sankar 1 , P. Sowjanya 2 and S. Madhubabu 2 1 University College of Pharmaceutical Sciences, Andhra University, Visakhapatnam-530003, India 2 Department of Pharmaceutical analysis, Dr. C.S.N Institute of Pharmacy, Bhimavaram, AP, India HO N CH 2 CH 2 CH 3 CH 3 CH 3 HO 3 Mg O 2 C Figure 1: Chemical Structure of Choline Magnesium Trisalicylate. Journal of Pharmaceutical Care & Health Systems J o u r n a l o f P h a r m a c e u ti c a l C a r e & H e a l t h S y s t e m s ISSN: 2376-0419