DEVELOPMENT AND VALIDATION OF ZERO AND FIRST ORDER SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF OPIPRAMOL IN BULK AND PHARMACEUTICAL DOSAGE FORM
Keywords:
Opipramol, Zero order spectra, First order, UV-spectrophotometric, Analytical method validationAbstract
Objective: Two simple, precise and accurate zero and first order spectrophotometric methods were developed and validated for the quantification of opipramol in bulk and tablet dosage form.
Methods: The quantitative analysis of the drug was carried out using the zero order and first order derivative values were measured at 254 nm and 266 nm respectively. The estimation of the drug was carried out by regression equations with the standard solution.
Results: Calibration graph was found to be linear r2 = 0.996 for zero order and r2 = 0.998 for first order derivative over the concentration range of 2-10 µg/ml. Precise (intra-day relative standard deviation [RSD] and inter-day RSD values < 1.0%), accurate (mean recovery = 100.77 %), specific and robust. No obstruction was observed from general pharmaceutical adjutants.
Conclusion: The developed derivative methods can be utilized in its routine analysis opipramol in quality control division.
Â
Downloads
References
Çelli II, Özmen E. Antidepressant choice in the outpatient department of a psychiatry clinic. Eur Neuropsychopharm 1996;6:S1.
Kees F, Bucher M, Mair G, Grobecker H. Determination of opipramol in human plasma by high-performance liquid chromatography with photometric detection using a cyanopropyl column. J Chromatography B 2001;753(2):337-42.
Kees F, Jehkul A, Bucher M, Mair G, Kiermaier J, Grobecker H. Bioavailability of opipramol from a film-coated tablet, a sugar-coated tablet and an aqueous solution in healthy volunteers. Arzneimittelforsch 2003;53(2):87-92.
Martin Dale. The extra pharmacopeia. 31st. London: Royal Pharmaceutical Society; 1996.
Kees F, Bucher M, Mair G, Grobecker H. Determination of opipramol in human plasma by high-performance liquid chromatography with photometric detection using a cyanopropyl column. J Chromatogr B Biomed Sci Appl 2001;753(2):337-42.
Erdal Turha, Bengi Uslu. Electroanalytical determination of opipramol in pharmaceutical preparations and biological fluids. Anal Lett 2008;41(11):2013-32.
ICH. Q2A validation of analytical procedures. Consensus Guidelines: ICH Harmonized Tripartite Guidelines; 1994.
ICH. Q2B validation of analytical procedures. Methodology, Consensus, Consensus Guidelines: ICH Harmonized Tripartite Guidelines; 1996.