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 (R2) 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.
Highlights
Curcumin is (1E, 6E)-1,7-bis (4-hydroxy-3-methoxyphenyl)1,6-heptadiene-3,5-dione [1]
Several bioanalytical methods which include reverse-phase high-performance liquid chromatography (RP-HPLC) [8], LC-MS [8] and RP-HPLC [8] were reported for the analysis of cyclosporine in soft gelatin capsule dosage [5]
The results obtained from the above set of observations prove that the present RP-HPLC method developed for the quantitative determination of curcumin and cyclosporine in the formulation was simple, sensitive, accurate, precise and robust
Summary
Curcumin is (1E, 6E)-1,7-bis (4-hydroxy-3-methoxyphenyl)1,6-heptadiene-3,5-dione [1]. Literature survey revealed LC-MS [2], RPHPLC [2], HPTLC [3], stability indicating HPLC [4], and UV spectrophotometric [1, 5,6,7] 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. It is (3S,6S,9S,12R,15S,18S,21S,24S,30S,33S)-30ethyl-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 (propan2-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 reported for the analysis of cyclosporine in soft gelatin capsule dosage [5]. The molecular structures of curcumin and cyclosporine is given in fig. 1
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