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Stability-indicating methods for the determination of piretanide in presence of the alkaline induced degradates.
J Pharm Biomed Anal. 2005 Oct 04; 39(5):871-6.JP

Abstract

Stability-indicating high performance liquid chromatography (HPLC), thin-layer chromatography (TLC) and first-derivative of ratio spectra (1DD) methods are developed for the determination of piretanide in presence of its alkaline induced degradates. HPLC method depends on separation of piretanide from its degradates on mu-Bondapak C18 column using methanol:water:acetic acid (70:30:1, v/v/v) as a mobile phase at flow rate 1.0 ml/min and UV detector at 275 nm. TLC densitometic method is based on the difference in Rf-values between the intact drug and its degradates on thin-layer silica gel. Iso-propanol:ammonia 33% (8:2, v/v) was used as a developing mobile phase and the chromatogram was scanned at 275 nm. The derivative of ratio spectra method (1DD) depends on the measurement of the absorbance at 288 nm in the first-derivative of ratio spectra for the determination of the cited drug in the presence of its degradates. Calibration graphs of the three suggested methods are linear in the concentration ranges 0.02-0.3 microg/20 microl, 0.5-10 microg/spot and 5-50 microg/ml, with mean percentage recovery 99.27+/-0.52, 99,17+/-1.01 and 99.65+/-1.01%, respectively. The three proposed methods were successfully applied for the determination of piretanide in bulk powder, laboratory-prepared mixtures and pharmaceutical dosage form with good accuracy and precision. The results were statistically analyzed and compared with those obtained by the official method. Validation of the method was determined with favourable specificity, linearity, precision, and accuracy was assessed by applying the standard addition technique.

Authors+Show Affiliations

Youssef NF
National Organization for Drug Control and Research (NODCAR), P.O. Box 29, Cairo, Egypt. gomagdy@yahoo.com

MeSH

AlkaliesCalibrationChromatography, High Pressure LiquidChromatography, Thin LayerDensitometryDiureticsDrug StabilityIndicators and ReagentsReproducibility of ResultsSpectrophotometry, UltravioletSulfonamidesTablets

Pub Type(s)

Journal Article

Language

eng

PubMed ID

16223647

Citation

Youssef, Nadia F.. "Stability-indicating Methods for the Determination of Piretanide in Presence of the Alkaline Induced Degradates." Journal of Pharmaceutical and Biomedical Analysis, vol. 39, no. 5, 2005, pp. 871-6.
Youssef NF. Stability-indicating methods for the determination of piretanide in presence of the alkaline induced degradates. J Pharm Biomed Anal. 2005;39(5):871-6.
Youssef, N. F. (2005). Stability-indicating methods for the determination of piretanide in presence of the alkaline induced degradates. Journal of Pharmaceutical and Biomedical Analysis, 39(5), 871-6.
Youssef NF. Stability-indicating Methods for the Determination of Piretanide in Presence of the Alkaline Induced Degradates. J Pharm Biomed Anal. 2005 Oct 4;39(5):871-6. PubMed PMID: 16223647.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Stability-indicating methods for the determination of piretanide in presence of the alkaline induced degradates. A1 - Youssef,Nadia F, Y1 - 2005/04/22/ PY - 2005/02/23/accepted PY - 2005/10/15/pubmed PY - 2006/2/9/medline PY - 2005/10/15/entrez SP - 871 EP - 6 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 39 IS - 5 N2 - Stability-indicating high performance liquid chromatography (HPLC), thin-layer chromatography (TLC) and first-derivative of ratio spectra (1DD) methods are developed for the determination of piretanide in presence of its alkaline induced degradates. HPLC method depends on separation of piretanide from its degradates on mu-Bondapak C18 column using methanol:water:acetic acid (70:30:1, v/v/v) as a mobile phase at flow rate 1.0 ml/min and UV detector at 275 nm. TLC densitometic method is based on the difference in Rf-values between the intact drug and its degradates on thin-layer silica gel. Iso-propanol:ammonia 33% (8:2, v/v) was used as a developing mobile phase and the chromatogram was scanned at 275 nm. The derivative of ratio spectra method (1DD) depends on the measurement of the absorbance at 288 nm in the first-derivative of ratio spectra for the determination of the cited drug in the presence of its degradates. Calibration graphs of the three suggested methods are linear in the concentration ranges 0.02-0.3 microg/20 microl, 0.5-10 microg/spot and 5-50 microg/ml, with mean percentage recovery 99.27+/-0.52, 99,17+/-1.01 and 99.65+/-1.01%, respectively. The three proposed methods were successfully applied for the determination of piretanide in bulk powder, laboratory-prepared mixtures and pharmaceutical dosage form with good accuracy and precision. The results were statistically analyzed and compared with those obtained by the official method. Validation of the method was determined with favourable specificity, linearity, precision, and accuracy was assessed by applying the standard addition technique. SN - 0731-7085 UR - https://www.unboundmedicine.com/medline/citation/16223647/Stability_indicating_methods_for_the_determination_of_piretanide_in_presence_of_the_alkaline_induced_degradates_ DB - PRIME DP - Unbound Medicine ER -