Development and Validation of Analytical Method for Determination of Valproate and Valproic Acid in Bulk and Pharmaceutical Dosage Form by Using RP-HPLC
Corresponding Author(s) : Thallapudi Yaswanth Ravi Teja
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 11 No. 3 (2023): 2023 Volume -11 - Issue 3
Abstract
A New RP-HPLC Method for the Simultaneous Estimation of Valproate and Valproic acid in bulk and its Pure and Pharmaceutical Dosage Form as per ICH Guidelines. The Present work was to develop a simple, fast, accurate, precise, reproducible, Reverse Phase High Performance Liquid Chromatographic Method for simultaneous estimation of Valproate and Valproic acid in pure and combined dosage form. Chromatographic separation was done using Symmetry ODS C18 column having dimension of 4.6×250mm having particle size of 5.0µm, with mobile phase consisting of Acetonitrile: Methanol in the ratio 65:45v/v, flow rate was adjusted to 1ml/min and detection wavelength at 256nm. The retention times of Valproate and Valproic acid was found to be 2.256 and 5.427 mins. The proposed method has been validated for accuracy, precision, linearity; robustness and range were within the acceptance limit according to ICH guidelines. Linearity for Valproate and Valproic acid was found in range of 6µg-14µg and 18µg-42µg and correlation coefficient was found to be 0.999 and 0.999% RSD for intermediate precision was found to be 0.5 and 0.3, for repeatability was 0.4 and 0.1, % mean recovery for Valproate and Valproic acid was found to be 101.326% and 100.501% respectively. The method was found to be robust even by change in the mobile phase ±2% and in more and less flow conditions. The developed method can be successfully employed for the routine analysis of Valproate and Valproic acid in bulk and Pharmaceutical dosage forms.
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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. Hand book 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.
- Dr. Kealey, Haines PJ. Analytical chemistry. 1st ed. Bios Publisher; 2002. P. 1-7.
- BraithWait A, Smith FJ. Chromatographic methods. 5th ed. Kluwer Academic Publishers; 1996. P. 1-2.
- Weston A, Phyllisr. Brown, HPLC principle and practice. 1st ed. Academic press; 1997. P. 24-37.
- Kazakevich Y, Lobrutto R. HPLC for pharmaceutical scientists. 1st ed. Wiley Interscience A JohnWiley & Sons, IncInc Publishing House; 2007. P. 15-23.
- Chromatography [online]. Wikipedia. Available from: http://en.wikipedia.org/wiki/Chromatography.
- Meyer VR. Practical high-performance liquid chromatography. 4th ed. England: John Wiley & Sons Ltd; 2004. P. 7-8.
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. Hand book 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.
Dr. Kealey, Haines PJ. Analytical chemistry. 1st ed. Bios Publisher; 2002. P. 1-7.
BraithWait A, Smith FJ. Chromatographic methods. 5th ed. Kluwer Academic Publishers; 1996. P. 1-2.
Weston A, Phyllisr. Brown, HPLC principle and practice. 1st ed. Academic press; 1997. P. 24-37.
Kazakevich Y, Lobrutto R. HPLC for pharmaceutical scientists. 1st ed. Wiley Interscience A JohnWiley & Sons, IncInc Publishing House; 2007. P. 15-23.
Chromatography [online]. Wikipedia. Available from: http://en.wikipedia.org/wiki/Chromatography.
Meyer VR. Practical high-performance liquid chromatography. 4th ed. England: John Wiley & Sons Ltd; 2004. P. 7-8.