Development and validation of analytical method for determination of amlodipine and benazepril in bulk and pharmaceutical dosage form by RP-HPLC
Corresponding Author(s) : Rayudu Hari Krishna
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 11 No. 3 (2023): 2023 Volume -11 - Issue 3
Abstract
A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Amlodipine and Benazepril, in its pure form as well as in capsule dosage form. Chromatography was carried out on an Altima C18 (4.6 x 150 mm, 5µm) column using a mixture of Methanol: TEA Buffer pH 4.5: Acetonitrile (50:25:25) as the mobile phase at a flow rate of 1.0 mL/min, the detection was carried out at 225 nm. The retention time of the Amlodipine and Benazepril was 2.102, 3.537 ±0.02 min respectively. The method produce linear responses in the concentration range of 5-25 mg/ml of Amlodipine and 20-100 mg/ml of Benazepril. The method precision for the determination of assay was below 2.0 %RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.
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- Shethi PD. HPLC- quantitative analysis of pharmaceutical formulations. 1st ed New Delhi: CBS Publishers & Distributors; 2001. p. 8-10, 101-3.
- Kasture AV, Mahadik KR, Wadodkar SG, More HN. Pune: Nirali Prakashan. J Pharm Anal. 8th ed. 2002;II:48-57.
- Prajapati GA. Method development and validation for simultaneous estimation of Hypertensive drugs by RP-HPLC [M.Pharm thesis]. Gujarat, India: Maliba Pharmacy College, Gujarat Technological University. p. 7-28; 2011.
- Gabor S. HPLC in pharmaceutical Analysis. 1st ed. Vol. I. London: CRC Press; 1990. p. 101-73.
- Jeffery GH, Bassett J. Vogel’s textbook of Quantitative Chemical Analysis. 5th ed. NY: John Wiley & Sons Inc; 1991. p. 217-35.
- Hobart HW, Merritt LL, John AD. Instrumental Methods of Analysis. 7th ed. New Delhi: CBS Publishers; 1988. p. 580-610.
- Sharma BK. Instrumental Method of Chemical Analysis. 20th ed. Meerut: Goel Publishing House; 2001. p. 54-83.
- Ashutoshkar. Pharmaceutical drug analysis. 2nd ed New Delhi. New Age International Publisher; 2005. p. 455-66.
- Ahuja S, Michael WD [handbook] of Pharmaceutical Analysis by HPLC. 1st ed. London: Elsevier Academic Press; 2005. p. 44-54.
- Snyder LR, Kirkland JL, Glajch JL. Practical HPLC method development. 3rd ed. New York: Wiley; 1988. p. 227.
- Skoog DA, West DM. Principles of instrumental analysis Saunders Golden Sunburst Series. 2nd ed. Philadelphia; 1980. p. 674-5, 690-6.
- Snyder LR, Kirkland JL, Glajch JL. Practical HPLC method development. 2nd ed. New York: Wiley; 1997. p. 1-19.
- Valkó K, Snyder LR, Glajch JL. Retention in Reversed-Phase Liquid chromatography as a function of mobile phase composition. J Chromatogr A. 1993;656(1-2):501-20. doi: 10.1016/0021-9673(93)80816-Q.
- Neue UD. HPLC columns: theory, technology and practice. 2nd ed. New York: John Wiley & Sons; 1997. p. 174-86.
- Kazakevich Y, Lobrutto R. HPLC for pharmaceutical scientists. 1st ed. NJ: John Wiley & Sons Inc; 2007. p. 987-1051.
References
Shethi PD. HPLC- quantitative analysis of pharmaceutical formulations. 1st ed New Delhi: CBS Publishers & Distributors; 2001. p. 8-10, 101-3.
Kasture AV, Mahadik KR, Wadodkar SG, More HN. Pune: Nirali Prakashan. J Pharm Anal. 8th ed. 2002;II:48-57.
Prajapati GA. Method development and validation for simultaneous estimation of Hypertensive drugs by RP-HPLC [M.Pharm thesis]. Gujarat, India: Maliba Pharmacy College, Gujarat Technological University. p. 7-28; 2011.
Gabor S. HPLC in pharmaceutical Analysis. 1st ed. Vol. I. London: CRC Press; 1990. p. 101-73.
Jeffery GH, Bassett J. Vogel’s textbook of Quantitative Chemical Analysis. 5th ed. NY: John Wiley & Sons Inc; 1991. p. 217-35.
Hobart HW, Merritt LL, John AD. Instrumental Methods of Analysis. 7th ed. New Delhi: CBS Publishers; 1988. p. 580-610.
Sharma BK. Instrumental Method of Chemical Analysis. 20th ed. Meerut: Goel Publishing House; 2001. p. 54-83.
Ashutoshkar. Pharmaceutical drug analysis. 2nd ed New Delhi. New Age International Publisher; 2005. p. 455-66.
Ahuja S, Michael WD [handbook] of Pharmaceutical Analysis by HPLC. 1st ed. London: Elsevier Academic Press; 2005. p. 44-54.
Snyder LR, Kirkland JL, Glajch JL. Practical HPLC method development. 3rd ed. New York: Wiley; 1988. p. 227.
Skoog DA, West DM. Principles of instrumental analysis Saunders Golden Sunburst Series. 2nd ed. Philadelphia; 1980. p. 674-5, 690-6.
Snyder LR, Kirkland JL, Glajch JL. Practical HPLC method development. 2nd ed. New York: Wiley; 1997. p. 1-19.
Valkó K, Snyder LR, Glajch JL. Retention in Reversed-Phase Liquid chromatography as a function of mobile phase composition. J Chromatogr A. 1993;656(1-2):501-20. doi: 10.1016/0021-9673(93)80816-Q.
Neue UD. HPLC columns: theory, technology and practice. 2nd ed. New York: John Wiley & Sons; 1997. p. 174-86.
Kazakevich Y, Lobrutto R. HPLC for pharmaceutical scientists. 1st ed. NJ: John Wiley & Sons Inc; 2007. p. 987-1051.