Abstract
To develop a simple and sensitive method for the simultaneous estimation of drotaverine HCL (DRH) and aceclofenac (AF) using RP-HPLC. The HPLC separation was achieved on a thermo column (250 mm × 4.6 mm, 5μ) with an isocratic mixture of acetonitrile and 5 mM of ammonium acetate in the ratio of 65:35, pH adjusted to 4.5 at a flow rate of 1.0 ml/min and the detection at 285nm. The method was validated as per ICH guidelines. The retention time for DRH and AF was 3.9 and 5.0 minutes, respectively. The optimized method was linear in the range of 50 - 120 ng/ml and 100 - 700 ng/ml for DRH and AF respectively. The overall recovery of DRH and AF were 99.8 and 99.5 % respectively. The developed sensitive, robust and rugged method as proven reproducibility of the result obtained as an outcome of small deliberate variation in the analytical parameter and the change the operator.
Highlights
Drotaverine hydrochloride (DRH) is chemically known as 1-[(3; 4-[diethoxyphenyl) methylene]-6; 7diethoxy-1; 2; 3; 4 – tetrahydroisoquinolene hydrochloride[1]
The aim of present study wasto propose a simple and sensitive method for quantification of DRHand AF to validate the procedures in order to demonstrate its good analytical and statistical parameters
Materials The chromatographic separation was achieved on a Shimadzu high-pressure liquid chromatographic system equipped with a binary LC-20AD solvent delivery system; SPD-20A Photo Diode Array (PDA) detector and SIL-20ACHT injector with 50 μL loop volume
Summary
Drotaverine hydrochloride (DRH) is chemically known as 1-[(3; 4-[diethoxyphenyl) methylene]-6; 7diethoxy-1; 2; 3; 4 – tetrahydroisoquinolene hydrochloride[1]. Drotaverine hydrochloride is highly potent spasmolytic agent[2]. Aceclofenac [AF] is chemically designated as 2-(2; 6-Dichloroanalino) phenyl acetoxy acetic acid. It is a NSAID; used in the management of osteoarthritis; rheumatoid arthritis; and ankylosing spondylitis[3]. A few UV spectrophotometric andHPLC[4,5,6,7] methods have been reported individually or in combination with other drugs for estimation of DRH. The aim of present study wasto propose a simple and sensitive method for quantification of DRHand AF to validate the procedures in order to demonstrate its good analytical and statistical parameters
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