Determination of Buspirone HCl in Commercial Dosage Forms by Extractive Spectrophotometric Method and Comparison by HPLC Method
Science Journal of Analytical Chemistry
Volume 3, Issue 6, November 2015, Pages: 91-99
Received: Nov. 7, 2014;
Accepted: Jan. 23, 2015;
Published: Oct. 22, 2015
Views 4540 Downloads 133
Syed Najmul Hejaz Azmi, Department of Applied Sciences, Chemistry Section, Higher College of Technology, Al-Khuwair-133, Muscat, Sultanate of Oman
Laila Talib Al-Ghafri, Department of Applied Sciences, Chemistry Section, Higher College of Technology, Al-Khuwair-133, Muscat, Sultanate of Oman
Samia Said Al-Ghafri, Department of Applied Sciences, Chemistry Section, Higher College of Technology, Al-Khuwair-133, Muscat, Sultanate of Oman
Maithaa Mohammed Al-Haribi, Department of Applied Sciences, Chemistry Section, Higher College of Technology, Al-Khuwair-133, Muscat, Sultanate of Oman
An extractive spectrophotometric method has been developed for the determination of buspirone HCl in tablets. It was based on the ion-pair complex formation between buspirone and bromothymol blue in presence of disodium hydrogen phosphate and citric acid buffer solution of pH 4.0 which is extractable in chloroform. The extracted complex showed maximum absorbance at 412 nm. Beer’s law was obeyed in the concentration range of 1.25-30 μg ml-1. Various factors affecting the reaction conditions were carefully studied and optimized. Validation parameters based on the guidelines of International Conference on Harmonisation, USA were followed. Effect of common excipients used as additives has been tested and the tolerance limit was calculated for the determination of buspirone HCl. Limits of detection and quantitation were 0.165 and 0.499 g ml-1, respectively. Proposed method has been successfully applied for the determination of buspirone HCl in pharmaceutical formulations. High performance liquid chromatographic method was employed using 250 mm × 4.6 mm i.d., 5-m particle, reversed phase C18 column with 70:30 (v/v) methanol-0.01M NaH2PO4 buffer as a mobile phase at a flow rate of 0.8 ml min-1 and UV detection at 240 nm for best separation of buspirone. Results obtained by the proposed method were statistically compared with the HPLC reference method using t- and F- values and found no significant difference between the two methods. The proposed method can be used as an alternate method for routine quality control analysis of buspirone HCl in pharmaceutical formulations.
Syed Najmul Hejaz Azmi,
Laila Talib Al-Ghafri,
Samia Said Al-Ghafri,
Maithaa Mohammed Al-Haribi,
Determination of Buspirone HCl in Commercial Dosage Forms by Extractive Spectrophotometric Method and Comparison by HPLC Method, Science Journal of Analytical Chemistry.
Vol. 3, No. 6,
2015, pp. 91-99.
British Pharmacopoeia, vol. I, Her Majesty Stationary Office, London, UK, 2014, p. 336.
Péhourcq F. Rapid high-performance liquid chromatographic measurement of buspirone in human plasma after overdose. Biomed Chromatogr 2004; 18:637-640.
Zaxariou M, Panderi I. Development and validation of a high-performance liquid chromatographic method for the determination of buspirone in pharmaceutical preparations. J Pharm Biomed Anal 2004; 35:41-50.
Foroutan SM, Zarghi A, Shafaati AR, et al. Simple high-performance liquid chromatographic determination of buspirone in human plasma. Il Farmaco 2004; 59:739-742.
Azeem A, Rizwan M, Ahmad FJ, Iqbal Z, Khar RK, Aqil M, Talegaonkar S. Development and validation of a stability-indicating LC-UV method for rapid analysis of buspirone in pharmaceutical dosage forms. Acta Chromatographica 2009; 21:283-297.
Rao MVB, Nagendrakumar AVD, Maiti S, Raja G. Validated RP-HPLC method for the determination of buspirone in pharmaceutical formulations, Chromatography Research International 2011;1-3.
Sabry SM, Barary MH, Abdel-Hay MH, et al. Adsorptive stripping voltammetric behaviour of azomethine group in pyrimidine-containing drugs. J Pharm Biomed Anal 2004; 34:509-516.
Chen S, Xu F, Zhang H, et al. Voltammetric determination of buspirone. Talanta. 1993; 40:1551-1555.
Mayol RF, Marvel CJ, LaBudde JA. Development and validation of a radioimmunoassay for buspirone. Fed Proc 1981; 40:684.
Kivisto KT, Laitila J, Martensson K, et al. Determination of buspirone and 1-(2-pyrimidinyl)-piperazine (1-pp) in human plasma by capillary gas chromatography. Ther Drug Monit 1999; 21:317-321.
Abdel-Ghani N, Issa Y, Shoukry A, et al. Flow injection analysis with tubular membrane ion-selective electrode and coated wires for buspirone hydrochloride. Ann Chim 2007; 97:97-107.
Kurien J, Kurian T, William H, et al. Simple spectrofluorimetric determination of buspirone hydrochloride in bulk drug and pharmaceutical dosage forms. Hygeia JD Med 2012, 4:6-14.
Dhandapani B, Hemamrutha S, Sravanthi LK, et al. Spectrophotometric estimation of buspirone hydrochloride in bulk and its pharmaceutical formulation. International Journal of Pharma Sciences and Research 2010; 4:211-216.
Kurien J. A sensitive spectrophotometric method for the quantitative determination of buspirone hydrochloride in pharmaceutical formulations. Hygeia JD Med 2012; 4:6-14.
Amanlou M, Keivani S, Sadri B, et al. Simple extractive colorimetric determination of Buspirone by acid-dye complexation method in solid dosage form, Research in Pharmaceutical Sciences 2009:4:11-18.
Czegan DAC, Hoover DK. UV-visible spectrometers: versatile instruments across the chemistry curriculum. J Chem Educ 2012; 89:304.
International Conference on Harmonisation, ICH Harmonised Tripartite Guideline- Text on Validation of Analytical Procedures. Fed Regist 1995; 60:11260.
Britton HTS. Solutions of known hydrogen ion concentration. In: Hydrogen ions, Volume I. Chapman and Hall Ltd, London; 1942. p. 305.
Mendham J, Denney RC, Barnes JD, et al. Statistics: Introduction to Chemometrics. In: Vogel’s Textbook of Quantitative Chemical Analysis, 6th edition. Pearson Education, Singapore; 2002. p. 137.
Hartmann C, Smeyers-Verbeke J, Pinninckx W et al. Reappraisal of hypothesis testing for method validation: detection of systematic error by comparing the means of two methods or of two laboratories. Anal Chem 1995; 67:4491–9.
Likussar W, Boltz DF. Spectrophotometric determination of extraction constants for certain metal 1-pyrrolidinecarbodithioates. Anal Chem 1971; 43:1265.
Sheikhzadeh M, Rohani S, Jutan A, et al. Solid-state characterization of buspirone hydrochloride polymorphs. Pharmaceutical Research 2006; 23:1043-1050.
Goldberg AH, Sakr AA. Anionic exchange polymer complexes of buspirone. US Patent, 2001; p. US 6,268,368 B1.
Socrates G. Infrared Characteristics Group Frequencies. John Wiley & Sons, New York; 1980. p. 115.
Nalimov VV. The Application of Mathematical Statistics to Chemical Analysis, Pergamon Press, Oxford; 1963. p. 167.