DEVELOPMENT AND VALIDATION OF A HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) METHOD FOR DETERMINATION OF FIPRONIL AND PYRIPROXYFEN IN A VETERINARY PHARMACEUTICAL PRODUCT
Abstract
In the present study, an analytical HPLC method was developed for the estimation of Fipronil, Pyriproxyfen, Benzyl alcohol, Butylhydroxyanisole (BHA) and Butylhydroxytoluene (BHT) and related substances from a veterinary pharmaceutical product. The method showed linearity in the range of 0.44-200% with a correlation coefficient of 0.99. The method was validated for different validation parameters such as: specificity (peak identification and interference study), precision, accuracy, linearity, robustness, limit of detection (LOD) and limit of quantitation (LOQ), stability of standard solutions and sample solution. The results were found to be within the acceptance limits as per ICH guidelines.
Keywords:
Fipronil, Pyriproxiyfen, Benzyl alcohol, BHA, BHT, HPLC, validationDOI
https://doi.org/10.25004/IJPSDR.2015.070123References
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2. Maddison JE, Stephen W, Small Animal Clinical Pharmacology, Elsevier Limited, 2008, pp. 226.
3. Ramasubramanian T, Paramasivam M, Jayanthi R, Chandrasekaran S. A simple and sensitive single-step method for gas chromatography-mass spectrometric determination of fipronil and its metabolites in sugarcane juice, jaggery and sugar. Food Chem. 2014; 150:408-413.
4. Farouk M, Hussein LA, El Azab NF. New HPLC and fluorimetric methods for the determination of pyriproxyfen and pyridalyl insecticide residues in tomatoes. J AOAC Int. 2014; 97(1):188-96.
5. VICH –GL1 – Guidance for industry - Validation of analytical procedures definition and terminology;
6. VICH-GL2 – Validation: Methodology – Gudeline on validation of analytical procedures;
7. CPMP/ICH/381/-ICH Q(R1);
8. VICH Topic GL10 –Quality: Impurities in new veterinary drug substances
9. VICH Topic GL11- Quality: Impurities in new veterinary medicinal product
10. Q1A, Stability Testing of New Drug Substances and Products. In the proceedings of the International Conference on Harmonization, Geneva, 1993.
11. Q2B, Validation of Analytical Procedure: Methodology. In the proceedings of the International Conference on Harmonization, Geneva, 1996.
2. Maddison JE, Stephen W, Small Animal Clinical Pharmacology, Elsevier Limited, 2008, pp. 226.
3. Ramasubramanian T, Paramasivam M, Jayanthi R, Chandrasekaran S. A simple and sensitive single-step method for gas chromatography-mass spectrometric determination of fipronil and its metabolites in sugarcane juice, jaggery and sugar. Food Chem. 2014; 150:408-413.
4. Farouk M, Hussein LA, El Azab NF. New HPLC and fluorimetric methods for the determination of pyriproxyfen and pyridalyl insecticide residues in tomatoes. J AOAC Int. 2014; 97(1):188-96.
5. VICH –GL1 – Guidance for industry - Validation of analytical procedures definition and terminology;
6. VICH-GL2 – Validation: Methodology – Gudeline on validation of analytical procedures;
7. CPMP/ICH/381/-ICH Q(R1);
8. VICH Topic GL10 –Quality: Impurities in new veterinary drug substances
9. VICH Topic GL11- Quality: Impurities in new veterinary medicinal product
10. Q1A, Stability Testing of New Drug Substances and Products. In the proceedings of the International Conference on Harmonization, Geneva, 1993.
11. Q2B, Validation of Analytical Procedure: Methodology. In the proceedings of the International Conference on Harmonization, Geneva, 1996.
Published
01-01-2015
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“DEVELOPMENT AND VALIDATION OF A HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) METHOD FOR DETERMINATION OF FIPRONIL AND PYRIPROXYFEN IN A VETERINARY PHARMACEUTICAL PRODUCT”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 7, no. 1, Jan. 2015, pp. 123-5, https://doi.org/10.25004/IJPSDR.2015.070123.
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How to Cite
“DEVELOPMENT AND VALIDATION OF A HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) METHOD FOR DETERMINATION OF FIPRONIL AND PYRIPROXYFEN IN A VETERINARY PHARMACEUTICAL PRODUCT”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 7, no. 1, Jan. 2015, pp. 123-5, https://doi.org/10.25004/IJPSDR.2015.070123.
