Comparative study of extension area based methods for spectrophotometric determination of desmopressin acetate in the presence of its acid-induced degradation products
Open Access
- 18 December 2022
- journal article
- research article
- Published by Springer Science and Business Media LLC in BMC Chemistry
- Vol. 16 (1), 1-10
- https://doi.org/10.1186/s13065-022-00906-x
Abstract
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.Keywords
This publication has 23 references indexed in Scilit:
- Desmopressin acutely decreases tachycardia and improves symptoms in the postural tachycardia syndromeHeart Rhythm, 2012
- Doping control analysis of desmopressin in human urine by LC-ESI-MS/MS after urine delipidationBiomedical Chromatography, 2012
- Qualitative detection of desmopressin in plasma by liquid chromatography–tandem mass spectrometryAnalytical and Bioanalytical Chemistry, 2012
- Regulatory peptides desmopressin and glutathione voltammetric determination on nickel oxide modified electrodesElectrochemistry Communications, 2011
- Concentration- and Temperature-Induced Effects of Incorporated Desmopressin on the Properties of Reverse Hexagonal MesophaseThe Journal of Physical Chemistry B, 2009
- Mean centering of ratio kinetic profiles as a novel spectrophotometric method for the simultaneous kinetic analysis of binary mixturesAnalytica Chimica Acta, 2004
- LC–MS determination of desmopressin acetate in human skin samplesJournal of Pharmaceutical and Biomedical Analysis, 2004
- Safe and Efficient Transdermal Delivery of Desmopressin Acetate by Iontophoresis in Rats.Biological & Pharmaceutical Bulletin, 1998
- Use of capillary electrophoresis and high-performance liquid chromatography for monitoring of glycosylation of the peptides dalargin and desmopressinJournal of Chromatography A, 1997
- Pharmacokinetics of 1‐deamino‐8‐d‐arginine vasopressin after various routes of administration in healthy volunteersClinical Endocrinology, 1993