Original Article ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF CURCUMIN AND CYCLOSPORINE BY RP-HPLC NEHA DESAI 1* , MUNIRA MOMIN 1 , UPASANA SINGH 2 , TABASSUM KHAN 3 , ATUL SHERJE 3 1 Department of Pharmaceutics, SVKM’s Dr. Bhanuben Nanavati College of Pharmacy, Vile Parle (W), Mumbai 400056, Maharashtra, India, 2 Junior Research Associate Formulation Development, Indoco Remedies Limited, Thane, Mumbai 400701, Maharashtra, India, 3 Department of Quality Assurance, SVKM’s Dr. Bhanuben Nanavati College of Pharmacy, Vile Parle (W), Mumbai 400056, Maharashtra, India Email: nihadesai27@gmail.com Received: 06 Aug 2018 Revised and Accepted: 20 Dec 2018 ABSTRACT Objective: The present work was undertaken with an aim to develop and validate a rapid reverse-phase high-performance liquid chromatography (RP-HPLC) method for the estimation of curcumin and cyclosporine in the capsule dosage form. Methods: The RP-HPLC method for the simultaneous estimation of curcumin and cyclosporine was developed using Agilent (Infinity 1260) HPLC system and Eclipse XDB-C18 (4.6 x 150 mm i.d., 5µ) stationary phase. The optimized mobile phase comprised of acetonitrile: water: methanol (50: 10: 40 v/v/v) pumped at a flow rate of 0.5 ml/min. Separation of drugs was achieved in an isocratic mode and elution was monitored using PDA detector at 214 nm. The method was validated as per ICH-Q2R1 guidelines. Results: Retention time of the curcumin and cyclosporine were found to be 3.073 min and 6.373 min with the correlation coefficient (R 2 ) of 0.9993 and 0.998 respectively. The response of curcumin and cyclosporine was found linear in the concentration range of 8-48 μg/ml and 4-24 μg/ml respectively. The percent recovery values were found in the range of 97-103% indicating satisfactory accuracy of the method. The percent relative standard deviation (% RSD) values for the precision study was less than 2 which suggest that the method is precise. Conclusion: The proposed method was found accurate, precise and specific for the determination of curcumin and cyclosporine in bulk as well as in capsule dosage form. Thus, the present method can be used for routine analysis and quality control of curcumin and cyclosporine in bulk and capsule dosage form. Keywords: Curcumin, Cyclosporine, ICH Guidelines, RP-HPLC © 2019 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/) DOI: http://dx.doi.org/10.22159/ijpps.2019v11i2.28975 INTRODUCTION Chemically, curcumin is (1E, 6E)-1,7-bis (4-hydroxy-3-methoxyphenyl)- 1,6-heptadiene-3,5-dione [1]. Literature survey revealed LC-MS [2], RP- HPLC [2], HPTLC [3], stability indicating HPLC [4], and UV spectrophotometric [1, 5-7] methods for estimation of curcumin alone or in combination with other drugs in bulk, in dosage forms and human plasma. Cyclosporine is an immunosuppressant drug used in post allogenic organ transplant to reduce the activity of patient's immune system. Chemically it is (3S,6S,9S,12R,15S,18S,21S,24S,30S,33S)-30- ethyl-33-[(E,1R,2R)-1-hydroxy-2-methylhex-4-enyl]-1,4,7,10,12,15,19, 25,28-nonamethyl-6,9,18,24-tetrakis (2-methylpropyl)-3,21-di (propan- 2-yl)-1,4,7,10,13,16,19,22,25,28,31-undecazacyclotritriacontane-2,5,8, 11,14,17, 20, 23, 26, 29, 32-undecone [8]. Several bioanalytical methods which include RP-HPLC [8], LC-MS [8] and RP-HPLC [8] were also reported for the analysis of cyclosporine in soft gelatin capsule dosage [5]. The molecular structures of curcumin and cyclosporine is given in fig. 1. Fig. 1: Molecular structure of (a) curcumin and (b) cyclosporine Till date, RP-HPLC method was not developed for the simultaneous estimation of curcumin and cyclosporine in the pharmaceutical dosage form. Therefore, the present study was attempted to develop a simple, accurate, precise and specific RP-HPLC method for quantitative determination of curcumin and cyclosporine in capsule dosage form for management of inflammatory bowel disorder (IBD). There is no marketed formulation of curcumin and cyclosporine (pellets in a capsule or any other pharmaceutical dosage form) for the management of IBD. The literature states that curcumin and cyclosporine, when used in combination, can successfully manage the remission of ulcerative colitis [9]. Therefore, a fixed-dose combination capsule formulation containing bioadhesive pellets of International Journal of Pharmacy and Pharmaceutical Sciences ISSN- 0975-1491 Vol 11, Issue 2, 2019