Stability-indicating RP-HPLC method for the determination of 6-gingerol in polyherbal formulations

被引：0

作者：

Kamal Y.K.T.K. ^{[1
]}

Singh M. ^{[2
]}

Ahmad S. ^{[2
]}

Alam P. ^{[1
]}

Salam S. ^{[3
]}

机构：

[1] Department of Pharmacognosy, College of Pharmacy, Salman Bin Abdulaziz University, P.O. Box 173, Al-Kharj

[2] Bioactive Natural Product Laboratory, Department of Pharmacognosy and Phytochemistry, aculty of Pharmacy, Hamdard University, Hamdard Nagar, 110062, New Delhi

[3] Department of Pharmaceutical Chemistry, College of Pharmacy, Salman Bin Abdulaziz University, P.O. Box 173, Al-Kharj

来源：

Journal of Analytical Science and Technology | / 6卷 / 1期

关键词：

6-Gingerol; Herbal compound formulation; HPLC; Stability; Validation;

D O I：

10.1186/s40543-015-0056-3

中图分类号：

学科分类号：

摘要：

Background: Among different systems medicine practiced worldwide, Unani medicine is the classical one and still commonly practiced in India and abroad for centuries. As it is widely used by a majority of population, it is necessary to come up with a systematic approach to develop well-designed methodologies for the quality control of different polyherbal formulations which are used for treatment of various diseases in this system of medicine. Methods: A reverse phase stability indicating HPLC method was developed for the determination of 6-gingerol in polyherbal formulations. Separation of 6-gingerol was achieved on reverse phase C18 (250 × 4.6 mm) column with a mobile phase containing methanol: 0.05% orthophosphoric acid in water (60:40, v/v) at 280 nm using UV-visible detector. The flow rate was kept as 1 mL/min. The proposed method was validated according to ICH guidelines for accuracy, precision, robustness, LOD, and LOQ, and statistical analysis proved method was accurate, precise, and robust. Results: The linear regression analysis data showed a good linear relationship (r2 = 0.9989 ± 0.0010) for 6-gingerol in the concentration range of 0.5 μg to 500 μg/mL. This proved the method can be employed for the determination 6-gingerol even in nanogram levels. The detection (LOD) and quantification (LOQ) limits were found to be 0.05 μg and 0.18 μg/mL, respectively. Satisfactory recovery results were observed from the herbal compound formulations (98.5 to 101%). Intra- and inter-day precisions of the method were found convincing, with relative standard deviation (%RSD) values in the range of 0.5 to 1.9%. Forced degradation studies of 6-gingerol was also carried out under different stress conditions which showed that the drug is stable in acidic and basic conditions whereas unstable against dry heat. Conclusions: Hence, newly validated HPLC method can be used for the quality control and standardization of different herbal formulations which contain Zingiber officianalis as one of the ingredients. © 2015, Kamal et al.

引用

共 14 条

[1]

Ahmad S., Rizwan M., Parveen R., Mujeeb M., Aquil M.A., Validated stability-indicating TLC method for determination of forskolin in crude drug and pharmaceutical dosage form, Chromatographia, 67, pp. 441-447, (2008)

[2]

Alam P., Ali M., Singh R., Madhurima A.S., Shakeel F., A validated HPLC method for estimation of cordifolioside A in Tinospora cardifolia, Miers and marketed formulations, J Chromatogr Sci, 47, pp. 910-913, (2009)

[3]

Amir S., Azhar I., Mazhar F., Hassan M.M., Ahmed S.W., Ahmad I., Usmanghani K., Shamim S., Kinetic studies on Zingiber officinale, Pak J Pharm Sci, 17, pp. 47-54, (2004)

[4]

New Delhi: Central Council of Research in Unani Medicine

[5]

2006, National Formulary of Unani Medicine, pp. 30-31, (2001)

[6]

Ansari M.J., Ahmad S., Kohli K., Ali J., Khar R.K., Stability–indicating HPTLC determination of curcumin in bulk drugs and pharmaceutical formulations, J Pharm Biomed Anal, 39, pp. 132-138, (2005)

[7]

Bilal A., Jamal A., Review Article- Unani System of Medicine, Phcog Rev, 1, pp. 210-214, (2007)

[8]

International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceutical for Human Use, “, pp. 1-13, (2005)

[9]

Jian Ping M.A., Xiao Ling J., Li Y., Li L.Z., Two new diarylheptanoids from the rhizomes of Zingiber officinale, Chin Chem Lett, 15, pp. 1306-1308, (2004)

[10]

Lee S., Khoo C., Halstead C.W., Huynh T., Bensoussan A., Liquid chromatographic determination of 6, 8, 10-gingerol, and 6-shogaol in ginger (Zingiber officinale) as the raw herb and dried aqueous extract, J AOAC Int, 5, pp. 1219-1226, (2007)

← 1 2 →