Abstract
A new simple, specific, precise and accurate reversed-phase liquid chromatography method has been developed for simultaneous estimation of Drotaverine HCl (DRO) and Nimesulide (NIM) in tablet formulation. The separation was achieved on a 5-micron C18 column (250 X 4.6 mm) using mobile phase consisting of a mixture of water: acetonitrile: methanol 30: 35: 35 % (pH 2.5, adjusted with orthophosphoric acid). The flow rate was maintained at 1.0 ml/min, with an average operating pressure of 2630 psi. The detection of the constituents was done using UV detector at 295 nm for DRO and NIM. The retention time of DRO and NIM were approximately 5.6 and 10.6 min respectively. Recovery study values of DRO and NIM is 100.06+ 0.40 and 100.13+ 0.34 respectively, relative standard deviation of less than 2% for the assay show that the method is precise, accurate and linear in the concentration given and demonstrate the method developed is rugged and robust. Linear response obtained for DRO was in the concentration range 50-250
Highlights
Drotaverine HCl chemically is (1-(3, 4-diethoxybenzylidene)-6, 7-diethoxy-1, 2, 3, 4-tetrahydroisoquin-oline) hydrochloride, is an isoquinoline derivative
Standard stock solution: An accurately weighed 50 mg of Drotaverine HCl (DRO) and 125 mg of NIM was transferred to 50.0 mL calibrated volumetric flask and dissolved in small volume of methanol and volume was made up to the mark with methanol
Working standard solution: 5.0 mL of standard stock solution was further diluted to 50.0 mL with mobile phase, the chromatogram of this solution was recorded (Fig. 2)
Summary
Drotaverine HCl chemically is (1-(3, 4-diethoxybenzylidene)-6, 7-diethoxy-1, 2, 3, 4-tetrahydroisoquin-oline) hydrochloride, is an isoquinoline derivative. It is a highly potent spasmolytic agent. It is a nonsteroidal anti-inflammatory drug 2. It is used for chronic arthritis (such as rheumatoid arthritis and osteoarthritis) surgery and posttraumatic acute pain and inflammation, otorhinolaryngological inflammation resulting in pain; dysmenorrhoea, upper respiratory tract infection symptoms such as fever treatment
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