Development and Validation of UV spectrophotometric method for the estimation of Curcumin in Bulk Drug and Pharmaceutical Dosage Forms

A rapid, simple, selective and precise UVVisible Spectrophotometric method has been developed for the determination of Curcumin in bulk forms and solid dosage formulations. The spectrophotometric detection was carried out at an absorption maximum of 421 nm using methanol as solvent. The method was validated for specificity, linearity, accuracy, precision, robustness and ruggedness. The detector response for the Curcumin was linear over the selected concentration range 1 to 7 μg/ml with a correlation coefficient of 0.9995. The accuracy was between 99.1& 101.4%. The precision (R.S.D.) among six sample preparations was 0.39%. The LOD and LOQ are 0.05 and 0.172 μg/ml, respectively. The recovery of curcumin was about 100.4 %. The results demonstrated that the excipients in the commercial tablets did not interfere with the method and can be conveniently employed for routine quality control analysis of Curcumin in bulk drug, marketed tablets and other formulations. *Corresponding author, Mailing address: Kiran Sharma II E 96/A, Nehru Nagar, Ghaziabad, 201001, U.P., India. Email id: [email protected] Article History:-----------------------Date of Submission: 12-03-2012 Date of Acceptance: 11-04-2012 Conflict of Interest: NIL Source of Support: NONE F U L L L e n g t h R e s e a r c h P a p e r C o v e r e d i n I n d e x C o p e r n i c u s w i t h I C V a l u e 4 .6 8 f o r 2 0 1 0 Int. J. Drug Dev. & Res., April-June 2012, 4 (2): 375-380 Covered in Scopus & Embase, Elsevier 375 curcumin, demethoxycurcumin, bisdemethoxycurcumin, zingiberene, curcumenol, curcumol, eugenol, tetrahydrocurcumin, triethylcurcumin, turmerin, turmerones, and turmeronols [2, 3]. Curcumin is the phytochemical that gives a yellow color to turmeric and is now recognized as being responsible for most of the therapeutic effects [4]. Chemically described as (1E, 6E)-1.7-bis (4 hydroxy – 3 methoxyphenyl) – 1,6 Heptadiene-3,5-dione, the aromatic ring systems, which are polyphenols are connected by two α, β – unsaturated carbonyl groups (Fig. 1), while the α,β – unsaturated carbonyl is a good Michael acceptor and undergoes nucleophilic addition [5, 6]. It is hydrophobic in nature and frequently soluble in dimethylsulfoxide, acetone, ethanol, and oils. It has an absorption maximum around 420 nm [7, 8]. Literature survey revealed that a variety of analytical methods viz. HPLC, HPTLC, UV-Visible has been developed for their analysis but in plasma and urine [9, 10]. As the formulations are available without combinations of any drugs, there is a need for coming up with analytical method which is simple, sensitive, rapid and accurate for estimation of Curcumin in pure form and in pharmaceutical preparations [11, 12]. Therefore, the aim of the present work is to develop and validate a method for the analysis by UV-Visible spectrophotometer which is easily adaptable as a routine in quality testing laboratories. This has enabled us to reduce total time of analysis besides taking care of the error caused due to incomplete extraction and use of internal standard. 2. MATERIALS AND METHODS 2.1. Materials Curcumin was obtained from Loba chieme Mumbai, India as gift sample. Methanol used was of analytical grade and purchased form Merk Chemicals, India. Three formulations collected from market (A, B & C) with drug equivalent to 500 mg curcumin. All the other chemicals and reagents used were of analytical grade. 2.2. Method development 2.2.1. Instrumentation Spectroscopic analysis was carried out using Doublebeam Shimadzu recording UV-Visible Spectrophotometer (Kyoto, Japan) model 1601 with 10 mm path length matched quartz cells was used for analytical purpose. 2.2.2. Standard stock solution Stock solutions of curcumin containing 10μg/ml were prepared in methanol and its aliquots were transferred in a series of 10 ml volumetric flasks in varying fractions and their volumes were made with methanol to prepare different standard dilutions varying in between 1-7μg ml-1. 2.2.3. Method optimization 2.2.3.1.. Selection and Optimization of Solvent It is well known that the solvent do exerts a profound influence on the quality and shape of the peak [13]. The choices of solvents for UV method development are: Chloroform, Acetone, Methanol etc. Different of solvents were optimized. Out of which methanol satisfied all the conditions relative to Peak quality & non-interference at the specified wavelength. 2.2.3.2. Selection of Wavelength The wavelength at which maximum absorption takes place in UV detector is selected for further analysis i.e. 421nm. 2.3. Method validation Validation of the method was carried out as per the International Conference on Harmonization (ICH) guidelines Q2 (R1) (ICH, 2005) [14]. And accordingly the parameters evaluated were: 2.3.1. Sensitivity Sensitivity of the method was determined with respect to limit of detection (LOD) and limit of F U L L L e n g t h R e s e a r c h P a p e r C o v e r e d i n I n d e x C o p e r n i c u s w i t h I C V a l u e 4 .6 8 f o r 2 0 1 0 Kiran Sharma et al: Development and Validation of UV spectrophotometric method for the estimation of Curcumin in Bulk Drug and Pharmaceutical Dosage Forms