Abstract
A simple, fast and precise reversed phase high performance liquid chromatographic method has been developed for the simultaneous determination of Camylofin dihydrochloride and Diclofenac Potassium using Methylparaben as an internal standard. Efficient __ chromatographic separation was achieved on Inertsil C 18 column (250mm x 4.6 mm, 5μm) as stationary phase with a mobile phase comprising of 0.05 M KH 2 PO 4 in water : Methanol (35:65,v/v) at a flow rate of 1.5mL min -1 , column temperature of 27°C and UV detection at 220 nm. The retention time of Methylparaben, Camylofin dihydrochloride and Diclofenac potassium were 3.60 min, 4.85 min and 13.10 min respectively. The proposed method was validated for linearity, accuracy, precision, sensitivity, robustness and solution stability. Linearity, accuracy and precision were found to be acceptable over the ranges of 250-750μg mL -1 for both camylofin dihydrochloride and diclofenac potassium. The test solution was found to be stable for 48 h. It can be conveniently adopted for routine quality control analysis.
Highlights
Camylofin dihydrochloride is 3-methylbutyl2-(2-diethylaminoethylamino)-2-phenyl-acetate hydrochloride is a drug used an antispasmodic
Water and acetonitrile in the ratio of 500:500, v/v was chosen for initial trail with a 25 cm length, 4.6 mm Citation: Rathnam MV, Singh RR (2010) Simultaneous RP HPLC Determination of Camylofin Dihydrochloride and Diclofenac Potassium in Pharmaceutical Preparations
When system suitability solution was injected in the above conditions the resolution between Methylparaben and Camylofin dihydrochloride was greater than 2.0, but the tailing factor of Camylofin dihydrochloride was greater than 2.2 and the retention time of Diclofenac potassium was found to be ~ 29 min
Summary
2-(2-diethylaminoethylamino)-2-phenyl-acetate hydrochloride is a drug used an antispasmodic. Diclofenac potassium is potassium-[(2, 6-dichlorophenyl) amino]-phenyl acetate. It is a potassium salt of an aryl acetic acid derivative. It possesses analgesic, anti-inflammatory, and antipyretic activity. The structure of the drug is shown in 1) One such combination contains 25 mg of Camylofin dihydrochloride and 25 mg of Diclofenac potassium. The literature revealed no method was available for simultaneous determination of this drug in such pharmaceutical preparation by HPLC [1-5]. An HPLC method was developed for determination of Camylofin dihydrochloride and Diclofenac potassium from their dosage form. The method described is simple, fast, precise and accurate for simultaneous determination of Camylofin dihydrochloride and Diclofenac potassium from pharmaceutical preparation
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