Development and validation of RP-HPLC method for loxapine in capsule dosage form
DOI:
https://doi.org/10.7439/ijapa.v5i3.1933Abstract
A reversed phase-high performance liquid chromatography (RP-HPLC) method was developed for the determination of loxapine drug in tablet dosage form. The developed method was validated by measuring linearity, precision, limit of detection (LOD), robustness and ruggedness, drug recovery and for system suitability. Water and acetonitrile in the ratio 55:45 v/v was the mobile phase with C 18 column (250 mm x 4.5 mm x 5 m) as a stationary phase and 265 nm was the detection wavelength. The HPLC system was operated in isocratic mode. The measured retention time of loxapine drug was 6.88 minutes and the limit of detection was 0.035 g/ml, respectively. The linearity measured in the range 10-100 g/ml had a correlation coefficient of 0.999. The results of the parameters precision, robustness, recovery and formulation assay indicate that the developed method is a very good tool for the analysis of loxapine drug in tablet dosage form in bulk.Downloads
References
Heel RC et al. Loxapine: a review of its pharmacological properties and therapeutic efficacy as an antipsychotic agent. Drugs 1978; 15(3): 198-217.
Martindale The Extra Pharmacopoeia, 31st ed, Royal Pharmaceutical Society of Great Britain, London, 1996.
US Pharmacopeia, 23rd ed, United States Pharmacopeial Convention, Rockville, MD, 1995.
Yu-guan W, Ri-fang L, Shao-fang C. Determination of loxapine in plasma by HPLC. Chinese J Hospital Pharm 2006; 26 (10): 1234.
Wen Yu-guan et al. Rapid determination of loxapine in plasma and clinical application. Pharmacy Today 2008; 2: 024.
Ao Z, Wei-giao H, Qing-xia C, Zhong W. Determination of loxapine in human plasma by RP-HPLC. Central South Pharmacy 2009; 6: 10.
Ao Z, Wei-giao H, Qing-xia C, Zhong W. Determination of the concentration of loxapine in human plasma by HPLC with UV detection. Strait Pharm J 2009; 6: 112.
Garcia LG, Bares IF, Pehourcq F, Jarry C. Simultaneous determination of four antipsychotic drugs in plasma by high performance liquid chromatography: Application to management of acute intoxications. J Chromatogr B 2003; 795(2): 257-264.
Zimmer JSD, Needham SR, Christianson CD et al. Validation of HPLC-MS/MS methods for analysis of loxapine, amoxapine, 7-OH-loxapine, 8-OH-loxapine and loxapine N-oxide in human plasma. Bioanalysis 2010; 2(12): 1989-2000.
Cheng SW, Tang SW, Remington G. Simultaneous quantitation of loxapine, amoxapine and their 7- and 8- hydroxy metabolites in plasma by high performance liquid chromatography. J Chromatogr 1991; 564(1): 213-21.
Mercolini L, Mandrioli R, Finizio G, Boncompagni G, Raggi MA. Simultaneous HPLC determination of 14 tricyclic antidepressants and metabolites in human plasma. J sep sci 2010; 33(1): 23-30.
Choong E et al. Therapeutic drug monitoring of seven psychotropic drugs and four metabolites in human plasma by HPLC-MS. J Pharm and Biomed anal 2009; 50 (5): 1000-1008.
Wong YC, Wo SK, Zuo Z. Investigation of disposition of loxapine, amoxapine and their hydroxylated metabolites in different brain regions, CSF and plasma of rat by LC-MS/MS. J Pharm and Biomed anal 2012; 58: 83-93.
Cooper TB and Kelly RG. GLC analysis of loxapine, amoxapine and their metabolites in serum and urine. J Pharm sci 1979; 68(2): 216-219.
Pucci V, Raggi M and Kenndler E. Separation of antipsychotic drugs (clozapine, loxapine) and their metabolites by capillary zone electrophoresis. J Chromatogr A 1999; 853(1-2): 461-468.
ICH Harmonized Tripartite Guideline Q2 (R1), Validation of analytical procedures: text and methodology, Current Step 4 Version, 2005.
Ohannesian L and Streeter AJ, Hand book of Pharmaceutical analysis, Marcel Dekker Inc. NewYork; 2002.
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