ASSAY OF FOUR PSYCHOTROPIC DRUGS CHLORPROMAZINE, CLOMIPRAMINE, AMITRIPTYLINE AND NORTRIPTYLINE IN TABLETS BY A SINGLE HPLC METHOD
Keywords:
HPLC, Chlorpromazine, Clomipramine, Amitriptyline, Nortriptyline, TabletsAbstract
Objective: The objective of the study was to develop and validate a novel and single HPLC method, which is a additional practical choice in quality control laboratories, in order to assay four psychotropic drugs chlorpromazine, clomipramine, amitriptyline and nortriptyline in tablets.
Methods: The chromatographic conditions comprised of a classical C8-type stationary phase (250 × 4.6 mm, 5μ), with a mobile phase consisting of 3g of sodium lauryl sulfate in a mixture of 400 ml of deionized water and 600 ml of acetonitrile, then 0.5 g of ammonium nitrate was added and apparent pH of 3.0 was adjusted with glacial acetic acid. The flow rate was 1 ml/min; the detection wavelength was at 254 nm under a temperature of 22 ○C.
Results: The method was validated for linearity with correlation coefficients very close to one, the accuracy with mean recovery values between 95.0-105.0%, precision with relative standard deviations of the calculated concentrations less than 5.0% and specificity in the presence of degradation products and excipients. Then it was used successfully to the assay of these drugs in tablets purchased from Syria. These analyzed tablets contained the active ingredient within 100±5% of stated concentration, within the limits specified by British Pharmacopeia.
Conclusion: The results presented in this paper showed that the developed method was simple and practical for the determination of the four drugs in tablets.
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