Quantitative determination of haloperidol in tablets by high performance thin-layer chromatography.

A densitometric high performance thin-layer chromatography (HPTLC) method was developed and validated for the quantitative analysis of haloperidol in tablets. Chromatographic separation was achieved on precoated silica gel F 254 HPTLC plates using a mixture of acetone/chloroform/n-butanol/acetic acid glacial/water (5:10:10:2.5:2.5 v/v/v/v/v) as the mobile phase. Quantitative analysis was carried out at a wavelength of 254 nm. The method was linear in the 10-100 ng/microL range, with a determination coefficient of 0.999. The coefficients of variation for precision were not higher than 2.35%. The detection limit was 0.89 ng/microL, and the quantification limit was 2.71 ng/microL. The accuracy ranged from 97.76 to 100.33%, with a CV not higher than 4.50%. This method was successfully applied to quantify haloperidol in real pharmaceutical samples, including the comparison with HPLC measurements. The method was fast, specific, with a good precision and accuracy for the quantitative determination of haloperidol in tablets.

[1]  I. Ali,et al.  Fast Determination of Haloperidol in Pharmaceutical Preparations Using HPLC with a Monolithic Silica Column , 2005 .

[2]  G. Shabir,et al.  Validation of high-performance liquid chromatography methods for pharmaceutical analysis. Understanding the differences and similarities between validation requirements of the US Food and Drug Administration, the US Pharmacopeia and the International Conference on Harmonization. , 2003, Journal of chromatography. A.

[3]  H. Trabelsi,et al.  Determination and degradation study of haloperidol by high performance liquid chromatography. , 2002, Journal of pharmaceutical and biomedical analysis.

[4]  V. Stella,et al.  Stability of Drugs and Dosage Forms , 2000, Springer US.

[5]  M. Kallel,et al.  Zero-crossing derivative spectrophotometry for the determination of haloperidol in presence of parabens. , 1998, Journal of pharmaceutical and biomedical analysis.

[6]  P. Duguid,et al.  Analysis of haloperidol tablets by high-performance liquid chromatography--an inter-laboratory study. , 1982, Journal of chromatography.

[7]  A. Maślanka,et al.  Densitometric high performance thin-layer chromatography identification and quantitative analysis of psychotropic drugs. , 2005, Journal of AOAC International.

[8]  AC Moffat,et al.  Clarke's analysis of drugs and poisons , 2003 .

[9]  A. Maślanka,et al.  Densitometric determination of impurities in pharmaceuticals. Part VI. Determination of 4,4-bis[4-(p-chlorophenyl)- 4-hydroxypiperidino]butyrophenone in haloperidol. , 2000, Acta poloniae pharmaceutica.

[10]  J. Chawla,et al.  SIMULTANEOUS DETERMINATION OF HALOPERIDOL AND BENZHEXOL HCI BY HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHY , 1996 .