Sagar Savale*, Hitendra Mahajan
*Department of Pharmaceutics, R. C. Patel institute of pharmaceutical education and research, Shirpur 425-405, dist. Dhule, Maharashtra, India
* Corresponding author,
Mr. Sagar Savale
Department of Pharmaceutics,
R. C. Patel Institute of Pharmaceutical
Education & Research, Shirpur, 425405,
dist. Dhule, Maharashtra, India.
Mobile No: +91 9960885333,
Email ID: firstname.lastname@example.org
Aim: UV Spectrophotometric Method Development and Validation for quantitative estimation of Diclofenac Sodium. Objective: U.V Spectrophotometric method have been widely employed for determination of analyte in a mixture. Our aim is to develop spectroscopic method for estimation of the diclofenac sodium in ternary mixture by using U.V spectrophotometry. Methodology: The method was validated as per ICH guidelines. The recovery studies confirmed the accuracy and precision of the method. Conclusion: It was successfully applied for the analysis of the drug in bulk and could be effectively used for the routine analysis. Key words: Diclofenac sodium, UV spectrophotometric method, Validation.
Diclofenac sodium belong to the family of non-steroidal anti-inflammatory drugs (NSAID) or cyclo-oxygenase (COX) inhibitors. It is an effective anti-inflammatory, analgesic and antipyretic agent. It is commonly used in the treatment of acute and chronic pain, rheumatoid and osteoarthritis. Chemically it is 2-(2, 6- dichlorophenyl) amino benzeneacetic acid 4-(3H 1, 2, dithiol-3-thione-5-yl) phenyl ester and is a low-molecular-weight drug (MWt: 318.13). The
present work describes the development of a simple, precise, accurate and reproducible
spectrophotometric method for the estimation of Diclofenac sodium in pharmaceutical dosage forms. The developed method was validated in accordance with ICH Guidelines and successfully employed for the assay Pharmaceutical preparation and dosage form (Kashiwame et al., 2011; Dangre et al., 2015; Sawale et al., 2015).
Material and Method
Diclofenac sodium supplied as a gift sample by Loba chem. Pvt. Ltd (Mumbai, India) used as working standard.
A double beam UV-VIS spectrophotometer (UV-1700, Shimadzu, Japan) connected to a computer loaded with spectra manager software UV Probe was used. The spectra were obtained with the instrumental parameters as follows: Wavelength range: 200–800 nm. All weights were taken on an electronic balance (Model Shimadzu AUX 120).
Preparation of standard stock solution
According to European pharmacopoeia, 10 mg of Diclofenac sodium was dissolve in 100 ml of methanol (100 µg/mL). Out of this stock 0.2-1.2 ml was pipetted and diluted up to 10 ml by methanol (2-12 µg/mL) and examined between 200-400 nm. The maximum absorbance was determined using UV-Vis Specrophotometer (UV-1700, Shimadzu, Japan) to confirm the λmax of the drugs.
Validation of analytical method
The analytical performance characteristics which may be tested during methods validation: % Recovery, Precision, Ruggedness and sensitivity (Han et al., 2003; Sharma et al., 2005; Aggarwal et al., 2006).
Results and Discussion
The solution of diclofenac sodium in methanol was found to exhibit maximum absorption at 276 nm after scanning on the UV-Vis spectrophotometer which was reported as λmax in the literature and the procured drug sample of diclofenac sodium complies with the reference spectra (Figure 1).