Development and validation of analytical method for determination of valproate and valproic acid in bulk and pharmaceutical dosage form by using RP-HPLC

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Vol. 11 No. 3 (2023): 2023 Volume -11 - Issue 3

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Published
August 16, 2023

Development and validation of analytical method for determination of valproate and valproic acid in bulk and pharmaceutical dosage form by using RP-HPLC

https://doi.org/10.61096/ijamscr.v11.iss3.2023.266-274
Thallapudi Yaswanth Ravi Teja
Department of Pharmaceutical Quality Assurance, Pydah College of Pharmacy Patavala, Andhra University, Kakinada, Andhra Pradesh,
B. Sravanasree
Department of Pharmaceutical Quality Assurance, Pydah College of Pharmacy Patavala, Andhra University, Kakinada, Andhra Pradesh,
D. Appalaraju
Department of Pharmaceutical Quality Assurance, Pydah College of Pharmacy Patavala, Andhra University, Kakinada, Andhra Pradesh,

Corresponding Author(s) : Thallapudi Yaswanth Ravi Teja

suralabs.publications@gmail.com

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.


 

Keywords

Valproate and Valproic acid RP-HPLC Validation Accuracy
1.
Thallapudi Yaswanth Ravi Teja, B. Sravanasree, D. Appalaraju. Development and validation of analytical method for determination of valproate and valproic acid in bulk and pharmaceutical dosage form by using RP-HPLC. Int. J. of Allied Med. Sci. and Clin. Res. [Internet]. 2023 Aug. 16 [cited 2025 Sep. 20];11(3):266-74. Available from: https://ijamscr.com/ijamscr/article/view/1390
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