Validation of Rapid Gas Chromatographic Method for Determination of Seven Volatile Compounds in a Urinary Tract Antiseptic Soft Gelatin Capsules

A simple, rapid and precise gas chromatographic method has been developed for simultaneous determination of seven volatile compounds namely alpha pinene, camphene, beta pinene, cineole, fenchone, borneol and anethol in urinary tract antiseptic soft gelatine capsule. The seven compounds were analysed by Gas chromatography-flame ionization detector (GC-FID) on a (5% diphenyl and 95% dimethylpolysiloxane) (30m x0.25mm x 0.25µm) column and Helium as a carrier gas. The injector and detector port temperatures were maintained at 200°C and 250°C respectively. Results of assay and recovery studies were statistically evaluated for its accuracy and precision. The correlation coefficient (r) values ranged from 0.997 to 0.9998. The detection limits ranged from 0.0015 to 0.014 mg ml−1. No interference from any components of pharmaceutical dosage forms was observed. According to the validation results, the proposed method was found to be specific, accurate and precise and could be applied to the simultaneous quantitative analysis of these seven volatile compounds in such pharmaceutical formulation. Keywords: Pharmaceutical analysis; Volatile compounds; Gas chromatography.

___

  • A. Nezhadali, M. Akbarpour and B. Zarrabi Shirvan , Chemical composition of the essential oil From the aerial parts of Artemisia Herba, E-J. Chemistry, 5, (2008), pp. 557- 561.
  • A. Nezhadali, B. Soleymani Roudi and M. Akbarpour, Chemical composition of the essential oils from the flower of Tanacetum Polycephalum Subsp. Duderanum as a herbal plant in Iran, Der Pharma Chemica, vol. 1, (2009), 27-31.
  • A. Nezhadali, M. Masrournia, A. Solati, M. Akbarpour and M. Nakhaei Moghadam, Analysis of the flower essential oil at different stages of plant growth and in vitro antibacterial abrotanoides Karal, In Iran, Der Pharma Chemica, 1, (2009), 146-150. Perovskia
  • A. Nezhadali, A. Khazaeifar, M. Akbarpour and M. Masrournia, Chemical composition of essential oil and antibacterial activity of Dracocephalum subcapitatum, J. Essent. Oil. Bearing Plant, 13, (2010), 112-117.
  • Burt S., Essential oils: their antibacterial properties and potential applications in foods. Journal of Food Microbiology 94, (2004), 223−253.
  • C. Wu, C. Feng, Y. Lo, T. Lin and J. Lo, Determination of volatile organic compounds in adsorption/thermal Chemosphere, 56, (2004), 71-80.
  • ICH (Validation of Analytical procedure: Methodology Conference on Harmonization, Food and Drug Administration, USA, November, 1996 and November, (2005). International
  • United State Pharmacopoeia 29 and National Formulary Convention, Rockville, MD, (2006). Pharmacopioeial
  • James N Miller& Jane C Miller, Statistics and Chemometrics for Analytical Chemistry, Fifth edition, Pearson Prenitce Hall, UK, (2005).