An Anti-Inflammatory Adrenocorticalsteroid Hydrocortisonesodiumsuccinate, Hydrocortisone Preparation and Validated for the Confirmation/ Determination and Quantification of Hydrocortisone

Volume 1 - Issue 5

Krishnasarma Pathy*

Received: September 12, 2018;   Published: September 21, 2018

DOI: 10.32474/LOJMS.2018.01.000121

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Abstract

Hydrocortisone is a naturally occurring corticosteroid hormone secreted by the adrenal cortex and released during times of stress. The synthetic drug is employed in the management of inflammatory and rheumatoid diseases, allergic conditions, and autoimmune disorders such as Addison’s disease (adrenal insufficiency disease). Hydrocortisone is commercially available in pharmaceutical formulations such as tablets, capsules, creams, ointments, and injections. Hydrocortisone may exist commercially as the unchanged hormone or as the acetate, cypionate, sodium phosphate, butyrate, valerate, and the sodium succinate forms. Preparation of the present paper provides a method for preparation of hydrocortisone , method for preparation of hydrogenation cortisone sodium succinate reaction temperature is low, fast, easy to produce during the reaction of other impurities, fewer side effects and was concentrated, high yield, where water and other solvents content is low, to lay the foundation for post-drying, hydrogenation of the hydrocortisone sodium succinate prepared in line with CP2005 and USP28 standards, for clinical use and also an isocratic sensitive and precise reverse phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the determination and quantification of hydrocortisone in controlled-release and conventional (tablets and injections) pharmaceutical preparations. Chromatographic separation was achieved on an ODS (C18), 5m, 4.6 × 150mm, with an isocratic elution using a freshly prepared mobile phase of composition methanol: water: acetic acid (60: 30: 10, v/v/v) at a flow rate of 1.0ml/min.

The detection of the drug was successfully achieved at a wavelength of 254 nm. The retention time obtained for the drug was 2.26 min. The proposed method produced linear detectable responses in the concentration range of 0.02 to 0.4 mg/ml of hydrocortisone. High recoveries of 98-101% were attained at concentration levels of 80%, 100%, and 120%. The intraday and interlay precision (RSD) were 0.19-0.55% and 0.33-0.71%, respectively. A comparison of hydrocortisone analyses data from the developed method and the official USP method showed no significant difference () at a 95% confidence interval. The method was successfully applied to the determination and quantification of hydrocortisone in six controlled-release and fifteen conventional release pharmaceutical preparations.

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