Perspective - (2023) Volume 13, Issue 2
Received: 20-Feb-2023, Manuscript No. IJP-23-93528; Editor assigned: 22-Feb-2023, Pre QC No. IJP-23-93528 (PQ); Reviewed: 13-Mar-2023, QC No. IJP-23-93528; Revised: 22-Mar-2023, Manuscript No. IJP-23-93528 (R); Published: 30-Mar-2023, DOI: 10.37532/2249-1848.2023.13(2).38
Hydrocortisone is a corticosteroid hormone that is naturally produced by the adrenal cortex and released during times of stress. The synthetic drug is used to treat inflammatory and rheumatic illnesses, allergies, and autoimmune disorders such as Addison's disease (adrenal insufficiency disease). Hydrocortisone is available in a variety of pharmacological forms, including pills, capsules, creams, ointments, and injections. Commercially available forms of hydrocortisone include the unmodified hormone as well as acetate, cypionate, sodium phosphate, butyrate, valerate, and sodium succinate. Modern chromatographic methods, such as High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC), are preferred for determining hydrocortisone in traditional pharmaceutical products such as pills, creams, and injections.
The various HPLC procedures use various chromatographic conditions, including the utilization of sophisticated and, at times, costly solvent systems. As a result, access to some of these solvent systems can be difficult in resource-poor developing countries. The development of a simple and inexpensive HPLC approach that uses easily accessible reagents for the identification and quantification of hydrocortisone in pharmaceutical formulations would be beneficial in resource-limited nations. The rise in autoimmune disorders, such as adrenal insufficiency, is a serious public health concern, and the long-term usage of standard hydrocortisone pills to treat such a condition is troublesome. Conventional hydrocortisone pill administration twice or three times day in individuals with adrenal insufficiency illness is incapable of reproducing the unique diurnal cortisol circadian rhythm. As a result, the majority of people with adrenal insufficiency continue to have inadequate therapeutic treatment, resulting in poor quality of life and increased mortality. In such extreme scenarios, there is a need for the creation of inventive and unique therapeutic models for hydrocortisone replacement therapy.
With the capacity to reproduce hydrocortisone's specific physiological rhythm, the utilization of controlled-release hydrocortisone oral dose formulations offers considerable promise. Moreover, such formulations are better equipped to monitor and control morning androgen levels. Accurate monitoring of the quality of these potential new pharmacological treatments is a necessary precondition for receiving quality healthcare. As compared to the immediate release pattern of traditional tablets, the enhanced treatment will improve patient compliance and ensure the distribution of regulated doses of hydrocortisone at the absorption site. The goal of this work was to create and verify a simple, sensitive, and repeatable isocratic reverse phase HPLC technique with Ultraviolet (UV)/visible detection for determining and quantifying hydrocortisone in conventional and controlled-release pharmaceutical formulations. Controlled-release hydrocortisone preparations continue to be the preferred formulations in the treatment of adrenal insufficiency illness. This disease is a potentially lethal autoimmune ailment that requires timely diagnosis and treatment to avert death. As compared to standard hydrocortisone solutions, the use of controlled-release formulations leads in more consistent cortisol concentrations during the diurnal cortisol circadian pattern.
Therefore, it is critical that appropriate and precise analytical procedures be made accessible to assess the quality of the goods in terms of their composition. This work focused on the development and validation of a simple isocratic RP-HPLC technique for determining hydrocortisone in both standard and controlled-release pharmaceutical formulations. A review of the literature shows that normal phase stationary support material and reverse phase stationary support material were used in the development of the HPLC technique and subsequent analysis of hydrocortisone products.
There is currently no reverse phase HPLC with UV detection technology that can analyze hydrocortisone in both conventional and controlled-release pharmaceutical formulations. The use of acetic acid as a modifier in the mobile phase system guaranteed that hydrocortisone was efficiently resolved with little matrix influence from both standard and controlled-release formulations. The use of readily accessible and cost-effective solvents in the mobile phase enabled efficient hydrocortisone resolution and separation on a reverse phase column.
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