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Paper Information

Journal:   JOURNAL OF ILAM UNIVERSITY OF MEDICAL SCIENCES   FALL 2009 , Volume 17 , Number 3; Page(s) 57 To 64.
 
Paper: 

DEVELOPMENT AND VALIDATION OF HIGH PERFORMANCE LIQUID CHROMATOGRAPHY WITH FLUORESCENCE DETECTION FOR ASSAY AND CONTENT UNIFORMITY OF IMIPRAMINE IN 10 AND 50 MG TABLETS

 
 
Author(s):  AKBARI ADERGANI B.*, ADIB N., HAJI MAHDIPOUR H.
 
* FOOD AND DRUG LABORATORY, RESEARCH CENTER (FDCRL), MINISTRY OF HEALTH AND MEDICAL EDUCATION, TEHRAN, IRAN
 
Abstract: 

Introduction: Imipramine is a widely prescribed tricyclic antidepressant. However, the routine control of this drug in assay and content uniformity requires a highly sensitive and precise analytical attitude. The aim of this research was to perform assay and content uniformity in tablet samples by high performance liquid chromatography with fluorescence detection.
Materials and Methods: As, nowadays, prescription of imipramine tablets is increasing, it seems necessary to improve their quality control. So, 10 and 50 mg tablets of imipramine were randomly collected from market retailers. The chemical structure and inherent fluorescence of imipramine were a good motivation for performing assay and content uniformity in tablet samples by developing and validation of high performance liquid chromatography and fluorescence detection. These experiments were compared with imipramine standards.
Findings: The results showed that imipramine could be determined by high performance liquid chromatography with fluorescence detection within 2 minutes. The detection limits(signal-to-noise ratio=3) for the examined antidepressant was 0.2ng/ml. Assay and content uniformity of the tested products met the requirements stated in accredited pharmacopoeias. Based on the statistical t-test, there is no significant difference between the test and reference products. (p>0.05)
Discussion & Conclusion: The results of this study demonstrated that the developed and validated HPLC method with sensitive florescence detection can be used in assay and content uniformity of imipramine. From intra- and inter-day coefficient of variations, it can be concluded that this method have a high accuracy and precision. Very low detection limit, wide dynamic range, appropriate accuracy and precision, ability in separation on a polymeric based PRP column in a short time with sufficient robustness are, certainly, the positive aspects of the developed and validated method.

 
Keyword(s): IMIPRAMINE, FLUORESCENCE DETECTION, LIQUID CHROMATOGRAPHY, ASSAY, CONTENT UNIFORMITY
 
References: 
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