ANALYTICAL METHOD VALIDATION OF AN HERBAL FORMULATION BY HEADSPACE GAS CHROMATOGRAPHY USING QBD
Abstract
Essential oils are rich sources of biologically active compounds possessing diverse medicinal properties. These form integral part of a number of herbal formulations. The most challenging part of commercialization of herbal formulation is to ensure consistency in quality from batch to batch. The aim of present study was to develop a validated gas chromatographic method based on quality by design (QbD) for routine quality control purpose.
A blend of essential oils possessing synergistic carminative properties was formulated in oily base. Ajowan oil, cardamom oil, caraway oil, coriander and fennel oil were selected for development of formulation. A gas chromatography method was developed for routine quality control purpose of the developed formulation by quality by design techniques (QbD). Each oil was characterized making use of a marker compound which was linalool for coriander oil, cineol for cardamom oil, anethol for fennel oil, carvone for caraway oil, thymol for ajowan oil and menthol for peppermint oil. Marker compound was characterized using mass spectroscopy. Chromatography method was established by quality by design approach and validated based on ICH guidelines.
Keywords:
Essential oil, gas chromatography, headspace analysis, marker compound, quality by design (QbD), Design of experiment (DoE)DOI
https://doi.org/10.25004/IJPSDR.2014.060406References
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21. Karmarkar S, Garber R, Genchanok Y, George S, Yang X, Hammond R. Quality by Design (QbD) Based Development of a Stability Indicating HPLC Method for Drug and Impurities. Journal of Chromatographic Science 2011; 49:439-446.
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26. ICH, Q2 (R1).Validation of Analytical Procedures: Text and Methodology, International Conference on Harmonization 2005.
2. Olivera P, Mila J, Mladen M. Chemical Composition and Antioxidant Activity of Essential Oils of Twelve Spice Plants. Croat. Chem. Acta. 2006; 79(4): 545-552.
3. Alpha GR, Kamat SD, Kamat DV. Antifungal Activity of Essential Oils against Fluconazole Resistant Fungi. International Journal of Phytomedicine 2011; 3: 506- 510.
4. Darughe F, Barzegar M, Sahari MA. Antioxidant and antifungal activity of Coriander (Coriandrum sativum L.) essential oil in cake. International Food Research Journal 2006; 19(3): 1253-1260.
5. Jeane S, Worku A, Sousa SM, Duarte VG, Machado MIL, Matos FJA. Analgesic and anti-inflammatory effects of essential oils of Eucalyptus. Journal of ethnopharmacology 2003; 89: 277–283.
6. El-Metwally EM. Evaluation of Antiulcer Activity of Ginger, Clove and Castor Oils against aspirin induced gastric ulcers in rats. World Applied Sciences Journal 2014; 29 (7): 815-824.
7. Philip JM, Robert S, Charles C. Gas chromatographic technologies for the analysis of essential oils. Journal of Chromatography A 2001; 936: 1–22.
8. Luigi M, Alessandro C, Peter QT, Rosaria C, Paola D, Giovanni D. Fast GC for the Analysis of Citrus Oils. Journal of Chromatographic Science 2004; 42: 410-416.
9. Mehdi H, Zeinab B, Saeide S, Yasub S. Antimicrobial activity of Trachyspermum ammi essential oil against human bacterial. International journal of Advanced Biological and Biomedical Research 2014; 2(1): 18-24.
10. Filomena S, Susana F, Joa o AQ, Fernanda CD. Coriander (Coriandrum sativum L.) essential oil: its antibacterial activity and mode of action evaluated by flow cytometry. Journal of Medical Microbiology 2011; 60: 1479–1486.
11. Wen RD, Qing PH, Hong ZA, Jian GX. Chemical composition, antibacterial activity and mechanism of action of essential oil from seeds of fennel (Foeniculum vulgare Mill.). Food Control 2014; 35: 109-116.
12. Keshavarz A, Minaiyan M, Ghannadi A, Mahzouni P. Effects of Carum carvi L. (Caraway) extract and essential oil on TNBS-induced colitis in rats. Research in Pharmaceutical Sciences 2013; 8(1): 1-8.
13. Rathore SS, Saxena SN, Balraj S. Potential health benefits of major seed spices. International Journal Seed Spices 2013; 3(2): 1-12.
14. Mi Kyoung L, Jun HL, Mi-Hee C, Jin-Hyun J, Yoon-Cheol N, Kwang-Won L, Jee HJ, Jongki H. Simultaneous Determination of Biological Marker Compounds in Ostericum koreanum by HPLC Method and Discrimination by Principal Component Analysis. Bulletine Korean Chemical Socity 2008; 29(12) 2465 – 2470.
15. Md. Rafiul H, Ansari SH, Abul KN, Kamran JN. Validated HPTLC analysis method for quantification of Thymol content in trachyspermum ammi and polyherbal unani formulation arq zeera. International Journal of Pharmacy and Pharmaceutical Sciences 2012; 4(3): 478-482.
16. Joanet M, Guy K, Simon G, Alvaro V, Sandy VV. The application of GC–MS combined with chemometrics for the identification of antimicrobial compounds from selected commercial essential oils. Chemometrics and Intelligent Laboratory Systems 2014; 130: 172–181.
17. Janka V, Alena B, Zuzana C. In-house validation of a simple headspace gas chromatography mass spectrometry method for determination of furan levels in food. Journal of Food and Nutrition Research 2007; 46(3): 123-127.
18. Naser M, Khalil P, Zahra B, Safar AD. Essential Oil Analysis by Headspace Solvent Microextraction coupled with Hydro-Distillation Method (HD-HSME) of Rosmarinus officinalis L. from Noshahr, Iran. Oriental Journal of Chemistry 2011; 27(4): 1317-1324.
19. Guilherme V, Julio SM, Alceu AJ. Validation of a manual Headspace Gas Chromatography method for determining volatile compounds in biological fluids. Labmedicine 2008; 39(1):42-45.
20. Devesh AB, Smita IR. QbD approach to analytical RPHPLC method development and its validation. International Journal of Pharmacy and Pharmaceutical Sciences 2011; 3(1):179-187.
21. Karmarkar S, Garber R, Genchanok Y, George S, Yang X, Hammond R. Quality by Design (QbD) Based Development of a Stability Indicating HPLC Method for Drug and Impurities. Journal of Chromatographic Science 2011; 49:439-446.
22. Raghava RTV, Raja KS, Mrutyunjaya R, Someswara RN. Development and validation of a stability indicating HPLC method for the estimation of rabeprazole impurities in pharmaceutical dosage forms by design of experiments. Asian Journal of Pharmaceutical and Research 2013; 6(4):43-51.
23. Deveshri B, Narkhede PD, Ravindra RP. Analytical method validation of gas chromatographic Method for the estimation of related substances in Trimethyl Otho Propionate. International Journal of Pharma and Bio Sciences 2010; 1(2): 1-24.
24. Nikhil G, Amit KG, Rajesh KS, Karan M, Rath G. Method development and validation for the GC assay of á-pinene in tea tree oil Formulation. Pharmacia. 2012, 1(3): 102-106
25. ICH, Q8 (R2). Pharmaceutical Development, International Conference on Harmonization 2009.
26. ICH, Q2 (R1).Validation of Analytical Procedures: Text and Methodology, International Conference on Harmonization 2005.
Published
01-10-2014
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“ANALYTICAL METHOD VALIDATION OF AN HERBAL FORMULATION BY HEADSPACE GAS CHROMATOGRAPHY USING QBD”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 6, no. 4, Oct. 2014, pp. 291-02, https://doi.org/10.25004/IJPSDR.2014.060406.
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How to Cite
“ANALYTICAL METHOD VALIDATION OF AN HERBAL FORMULATION BY HEADSPACE GAS CHROMATOGRAPHY USING QBD”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 6, no. 4, Oct. 2014, pp. 291-02, https://doi.org/10.25004/IJPSDR.2014.060406.
