Comparative study of extension area based methods for spectrophotometric determination of desmopressin acetate in the presence of its acid-induced degradation products

BMC Chemistry

Research

Khadiga M. Kelani¹  Samir Morshedy²  Gamal A. Omran²  Wael Talaat²  Ahmed M. Wafaa Nassar³ 

[1] Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini St., P.O. Box 11562, Cairo, Egypt;Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Damanhour University, Damanhour, Egypt;Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Modern University for Technology and Information (MTI), Cairo, Egypt;

关键词: Desmopressin acetate (DPA);    First derivative;    Derivative ratio;    Ratio difference;    Mean centering;    Dual wavelength;   

DOI  :  10.1186/s13065-022-00906-x

 received in 2022-09-27, accepted in 2022-11-25,  发布年份 2022

来源: Springer

【 摘 要 】

Desmopressin acetate (DPA) is a synthetic analogue of vasopressin used in the treatment of diabetes insipidus, bedwetting, hemophilia A, and elevated levels of urea in the blood. Sensitive and selective stability-indicating methods are needed to be developed and validated for its assay pure and pharmaceutical dosage forms in the presence of its degradation products as no method has been reported for its determination in the presence of its degradants. This work describes a comparative study of five simple stability-indicating spectrophotometric techniques for determination of DPA in presence of its acid-degradation products (acid-degradants) without prior separation. The proposed spectrophotometric techniques (First derivative, Derivative ratio, Ratio difference, Mean centering and Dual wavelength) were developed and validated according to ICH guidelines. Acid degradation was carried out with 0.1 N HCl; the acid-degradants were separated on TLC plates and the acidic degradation pathway was established by IR, H-NMR and MS techniques. The TLC method was based on the separation of DPA and its acid-induced degradation products on silica gel plates using methanol: water (80:20, v/v) as a developing system and UV detection at 254 nm. All assay suggested methods were successfully applied for quantitation of DPA in pure and tablet forms. They are specific, sensitive, precise and accurate. They showed good linearity in the concentration range of 1–14 µg/mL with good correlation coefficients, and limit of detection (LOD) of 0.304, 0.274, 0.167, 0.248 and 0.199 and limit of quantitation (LOQ) of 0.920, 0.829, 0.506, 0.751 and 0.604) for each method, respectively. These methods were successfully applied for the simultaneous determination of DPA in its pure and tablet dosage form in the presence of its acid-degradants. The results obtained were statistically comparable with those of reported HPLC assay method; no significant differences were observed with relevance to accuracy and precision. All the methods are sensitive, selective and can be used for the routine analysis of DPA in its pure and dosage forms.

【 授权许可】

CC BY   
© The Author(s) 2022

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