DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING RP-HPLC METHOD FOR THE DETERMINATION OF XIPAMIDE IN PURE AND DOSAGE FORMS

Abstract

Objective: A simple, selective, precise and stability-indicating RP-HPLC-method was developed and validated for the determination of xipamide (XIP).Methods: Stability tests were done through exposure of the analyte solution to thermal, photolytic, hydrolytic and oxidative stress conditions. The chromatographic separation was carried out in less than five min on a RP stainless-steel C-18 analytical column (150 mm ×4.6 mm ID, 5 µm) with an isocratic elution system of 0.023 M orthophosphoric acid of pH 2.6 and acetonitrile as the mobile phase in the ratio of 60: 40 at 1.5 ml/min flow rate at room temperature. A diode array UV was used at 220 nm for detection.Results: The degradation products were well separated from the pure drug. The elution time of XIP was found to be 4.561±0.024 min. The method was validated in terms of linearity, accuracy, precision, limit of detection (LOD), limit of quantitation (LOQ) and robustness. Good linearity was found in the concentration range of 1–100 µg/ml with a correlation coefficient of 0.9999. Intraday and interday precision were within 1.4%. LOD and LOQ were 0.088 μg/ml and 0.267 μg/ml, respectively and percentage recovery of XIP was found to be 99.92±1.02 %. Conclusion: The proposed method was successfully applied to the determination of XIP in pure form and in its pharmaceutical preparation without interference from its degradation products.Keywords: Xipamide, Stability indicating RP-HPLC, Stress degradation, Pure form, Dosage forms

Authors and Affiliations

Heba M. El-sayed, Soad S. Abd El-hay

Keywords

Related Articles

IN VIVO TOXICITY STUDIES OF BIOSYNTHESIZED SILVER NANOPARTICLES USING BRASSICA OLERACEAE IN ZEBRA FISH MODEL

Objective: Nanotechnology opens new applications in many fields including medicine, material science and various technologies. The aim of the current study is to synthesise nanoparticles of Brassica oleraceae by green ch...

DEVELOPMENT AND CHARACTERIZATION OF POLYCAPROLACTONE (PCL)/POLY ((R)-3-HYDROXYBUTYRIC ACID) (PHB) BLEND MICROSPHERES FOR TAMOXIFEN DRUG RELESE STUDIES

Objective: The objective of this study was to formulate and evaluate the drug release studies using Poly (ε-caprolactone) (PCL)/and Poly (R)-3-hydroxy butyric acid (PHB) blend microspheres for controlled release of Tamo...

V. NEGUNDO, L. CAMARA AND B. VARIEGATA PLANTS LEAF EXTRACT EXHIBIT CONSIDERABLE IN VITRO ANTIOXIDANT AND ANTICANCER ACTIVITIES

Objective: The study was planned to investigate antioxidant and anticancer activities with the preliminary phytochemical analysis of methanolic extracts of Vitex negundo (V. negundo), Lantana camara (L. camara) and Bauha...

EFFECT OF AMLODIPINE AND ENALAPRIL ON WOUND HEALING IN DIABETIC WISTAR ALBINO RATS

Objective: A number of structural and functional mechanisms have been identified in the pathogenesis of impaired wound healing in diabetes. Diabetes promotes endothelial dysfunction as evidenced by decreased nitric oxide...

DETERMINATION AND CHARACTERIZATION OF PROCESS IMPURITIES IN PAZOPANIB HYDROCHLORIDE DRUG SUBSTANCE

Objective: To develop a rapid, sensitive, accurate, precise and linear Reverse-Phase High-Performance Liquid Chromatographic (RP-HPLC) method and validate as per ICH guidelines for the quantitative estimation of Pazopani...

Download PDF file
  • EP ID EP577663
  • DOI -
  • Views 55
  • Downloads 0

How To Cite

Heba M. El-sayed, Soad S. Abd El-hay (2016). DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING RP-HPLC METHOD FOR THE DETERMINATION OF XIPAMIDE IN PURE AND DOSAGE FORMS. International Journal of Pharmacy and Pharmaceutical Sciences, 8(5), 366-371. https://europub.co.uk./articles/-A-577663