RP-HPLC Method Development and Validation for Estimation of Diclofenac Sodium in Soft Gelatin Capsule Dosage form

OBJECTIVE AND PLAN:The drug analysis plays an important role in all aspects regarding the drug right the development to the therapeutic use of the drug. Industries manufacturing pharmaceutical must ensure that the raw material used and the final product obtained meets the required specification to fulfill this purpose they rely upon quantitative chemical analysis. The Literature survey indicates that a very few methods were developed for the estimation of Diclofenac Sodium by RP-HPLC. So an attempt was made to develop a new RP-HPLC method which is more reliable, economical and flexible. The objective of the present work is to develop a new method of estimation for Diclofenac Sodium in all formulations. So an attempt was made to develop and validate a simple, precise, accurate, linear and rapid RP-HPLC method as per ICH guidelines for the estimation of Diclofenac Sodium in pure pharmaceutical dosage forms and to apply the developed method to determine the validation of compounds. Plan of Work To obtain thorough knowledge of Practical RP-HPLC method. To establish the initial chromatographic conditions for method development of assay for Diclofenac Sodium . To validate the developed method a per the Q2 specifications of ICH guidelines SUMMARY AND CONCLUSION: A RP-HPLC method is developed and validated as per ICH guidelines for simultaneous estimation of Diclofenac Sodium in soft gelatin dosage form. In present study an attempt has been made to modify experimental condition, in order to estimate the drugs. The mobile phase was selected after trying various combinations of polar solvents. The proportion of solvents and variation of buffers was found to be quite critical as slight variation in it adversely affected the resolution of peaks. Considering all the fact the following parameter were finally fixed for this method Chromatographic conditions: Equipment : High performance liquid chromatography Column : C18, 15 cm x 4.6 mm, 5 μm Flow Rate : 1.0 mL/minute Pump mode : Isocratic Detector wavelength : 254 nm Injection volume : 20 μL Column Temperature : 25.0˚C Sample Temperature : 20.0˚C Run time : 7 Min The proposed method was found to be rapid, accurate, precise, specific, robust, rugged and economical. The mobile phase is simple to prepare and economical. The sample recoveries in all formulations were in good agreement with their respective label claims and they suggested non-interference of formulation excipients in the estimation. This method is also having an advantage than reported method that the retention time of the drugs is below 8 mins and the drugs can be assayed with the short time. Thus the method is not time consuming and can be used in laboratories for the routine analysis of combination drugs