DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR QUANTITATIVE ESTIMATION OF NIMBOLIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM
Keywords:
Nimbolide, RP- HPLC, ICH guidelinesAbstract
Objective: The present study was aimed to a simple, new, rapid and highly sensitive Reverse Phase - High Performance Liquid Chromatographic (RP-HPLC) method has been developed and an assay was validated for the quantitative estimation of nimbolide in solid dosage form.
Methods: The chromatographic separation was achieved on an Agilent 1200 series HPLC system C18 (250 mm x 4.6 mm x 2.5 μ) column packing by using isocratic mobile phase consisting of acetonitrile: water (90:10 v/v), flow rate was adjusted to 1.0 ml/min at a fixed wave length of 207 nm.
Results: The nimbolide was eluted at 2.880 ± 0.05 min and established a dynamic range of linearity over the concentration range of 3.125-200 ppm/ml (r2 = 0.9997 ± 0.005). The lower limit of detection and quantification was 0.007 ppm/ml and 0.021 ppm/ml respectively. The method was validated as per ICH guidelines. The accuracy of the method was determined by the recovery studies and the mean recovery was obtained 98.27%. Moreover the method was shown good reproducibility and recovery with percent relative standard deviation less than 2%.
Conclusion: Rapid, efficient and sensitive RP-HPLC method was developed for the estimation of nimbolide from the perspective of reducing the cost of analysis and time and thus by saving laboratory resources.
Â
Downloads
References
Negi Sunil Bhawna, Dave P Bharti. In vitro antimicrobial activity of Acacia catechu and its phytochemical analysis. Indian J Microbial 2010;50(4):369-74.
Kofi Annan, Stephen Gbedema, Francis Adu. Antibacterial and radical scavenging activity of fatty acids from Paullinia pinnata L. Pharmacognosy Magazine 2009;5 (19):119-23.
Kanthal Lakshmi kanta, Dey Akalanka, Satyavathi K, Bhojaraju P. Antibacterial potential of methanolic extract of Gyrocarpus asiaticus willd. Asian J Pharm Clinres 2014;(7, Suppl 1):192-4.
Sindiri Manoj kumar, Machavarapu Manasa, Vangalapati Meena. Antibacterial activity of methanolic extracts of Zephyranthes candida. Asian J Pharm Clinres 2013;(6, Suppl 5):112-3.
Sekar Mahendran, Ting CP, Abdullah Mahamad SB, Nalina K. Comparative evaluation of antibacterial properties of red & white Ginger. Asian J Pharm Clin Res 2014;7(1):108-10.
Suresh G, Geetha Gopalakrishnan, Wesley SD, Pradeep Singh, ND Malathi, Rajan SS. Insect anti-feedant activity of tetranortriterpenoids from the Rutales. A perusal of structural relations. J Agric Food Chem 2002;50:4484-90.
Rochanakij S, The btaranonth, Y Yanjai, C Yutharong Y. Nimbolide, a constituent of Azadirachta indica inhibits plasmodium falciparum in culture. South East Asian J Trop Med Pub Health 1985;16:66-72.
Nasiruddin Ahmad Farooqui, Akalanka Dey, G N Singh, T S Easwari. Antibacterial potential of Nimbolide from Azadirachta indica. Int J Pharm Pharm Sci 2014;6 (5):636-8.
Rojanpo W, Suwanno S, Somjaree R, Glinsukon T, Thebtaranont Y. Mutagenic and antibacterial activity testing of nimbolide and nimbic acid. J Sci Soc Thail 1985;11:177-8.
Kigodi PGK, Blaskc G, Thebtaranonth Y, Pezzuto JM, Cordell GA. Spectroscopic and Biological Investigation of Nimbolide and 28-Deoxonimbolide from Azadirachta indica. J Nat Prod 1989;52:1246-51.
Cohen E, Quistad GB, Casida JE. Cytotoxicity of nimbolide, epoxyazadiradione and other limonoids from neem insecticide. Life Sci 1996;58:1075–81.
Glinsukon T, Somjaree R, Piyachaturawat P, Thebtaranonth Y. Acute toxicity of nimbolide and nimbic acid in mice, rats and hamsters. Toxicol Lett 1986;30:159–6.
ICH, Q2A Text on validation of analytical procedures, International Conference on Harmonization, Oct 1994.
B., International M. ICH, Q3 of analytical procedures: on Harmonization, Nov. 1996.