HPTLC Approach for Simultaneous Quantification of Valsartan and Sacubitril in Bulk and Tablet Formulations
1 Department of Quality Assurance, DCS’s A. R. A. College of Pharmacy, Nagaon, Dhule, MS India.
2 Department of Pharmaceutical Chemistry, R. C. Patel Institute of Pharmaceutical Education and Research, Karwand Naka, Shirpur, Dist. Dhule -425 405, India.
3 Department of Pharmaceutical Chemistry, Gangamai College of Pharmacy, Nagaon, Dhule, MS India.
4 Department of Quality Assurance, R. C. Patel Institute of Pharmacy, Shirpur, Dist. Dhule MS India
Research Article
World Journal of Advanced Research and Reviews, 2024, 23(03), 3110–3119
Publication history:
Received on 21 August 2024; revised on 28 September 2024; accepted on 30 September 2024
Abstract:
The article introduces an inventive, eco-friendly, simple, consistent and reproducible NP-TLC-Densitometry approach to simultaneous pharmaceutical estimation of Valsartan and Sacubitril in bulk and tablet matrix. Valsartan and Sacubitril is a combination of two medications used to treat high blood pressure (hypertension). This combination is used when a single drug is not enough to control blood pressure. The determination was performed by employing densitometric estimation using ultraviolet exposure at 252 nm. The separation was achieved on (10 × 10 cm) aluminium backed silica gel 60-F254 as stationary phase. Optimized mobile phase was dichloroethane: methanol: triethylamine (4.2:0.4:0.4 v/v/v). Quantitation was conducted over a concentration range of 260 - 1560 ng/band of valsartan and 240 - 1440 ng/band of sacubitril. The compact and well-resolved bands for both drugs in standard and samples were obtained at a retention factor (Rf) value of 0.57 ± 0.02 and 0.42 ± 0.02 for valsartan and sacubitril respectively. As per International Council for Harmonization the established method was successfully validated to various parameters like accuracy, precision, sensitivity, specificity, robustness and shows the satisfactory results for all parameters. The recognized method is simple, accurate, precise, robust, sensitive and economical in nature. This method can be used for quality control of Valsartan and Sacubitril in bulk and in combined dosage form.
Keywords:
Valsartan; Sacubitril; HPTLC; ICH
Copyright information:
Copyright © 2024 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0