A simple and stability-indicating high performance liquid chromatographic method was developed and validated for the determination of miconazole nitrate in bulk and cream preparations. The extraction step for cream samples consisted in a warming, cooling and centrifugation procedure that assures the elimination of the lipophilic matrix component, in order to avoid further precipitation in the chromatographic system. Separation was achieved on a ZORBAX Eclipse XDB - C18 (4.6 mm x 150 mm, 5 microm particle size) column, using a mobile phase consisting of water, methanol and acetonitrile, in a flow and solvent gradient elution for 15 min. The column was maintained at 25 degrees C and 10 microL of solutions were injected. UV detection was performed at 232 nm, although employment of a diode array detector allowed selectivity confirmation by peak purity evaluation. The method was validated reaching satisfactory results for selectivity, precision and accuracy. Degradation products in naturally aged samples could be simultaneously evaluated, without interferences in the quantitative analysis.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.talanta.2009.04.060 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
A simple, cost-efficient stability-indicating RP-HPLC method for simultaneous estimation of embelin and piperine for routine analysis of marketed polyherbal capsules and tablets.
Nat Prod Res
January 2025
Teerthanker Mahaveer College of Pharmacy, Teerthanker Mahaveer University, Moradabad, UP, India.
Embelin (EMB) and Piperine (PIP) alkaloids are reported for -antidiabetic, hypolipidemic, antioxidant, and anti-cancer properties. However, simultaneous analytical methods are scarce. A stability-indicating RP-HPLC method was developed with mobile phase MeOH: 0.
View Article and Find Full Text PDFAdvanced stability-indicating RP-HPLC method for the quantification of lurasidone hydrochloride in bulk and PLGA-based in situ implant formulation.
Ann Pharm Fr
October 2024
Amity Institute of Pharmacy, Amity University Uttar Pradesh, Noida, Uttar Pradesh 201301, India. Electronic address:
Objectives: The aims of the present investigation was to develop and validate stability-indicating RP-HPLC method for the estimation of Lurasidone hydrochloride (LURA-H) followed by its drug product, LURA-H encapsulated poly-D,L lactic-glycolic acid (PLGA) based in situ depot forming implant (LURA-H-PLGA-ISI).
Methods: The LURA-H-PLGA-ISI formulation was developed by simple mixing method. According to international conference on harmonization guidelines, RP-HPLC method was developed and validated using Waters 2695 and discovery C18, 5μ, 250×4.
Evaluating the Compatibility of Three Aluminum Salt-Adjuvanted Recombinant Protein Antigens (Trivalent NRRV) Combined with a Mock Trivalent Sabin-IPV Vaccine: Analytical and Formulation Challenges.
Vaccines (Basel)
September 2024
Department of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center, University of Kansas, Lawrence, KS 66047, USA.
In this work, we describe compatibility assessments of a recombinant, trivalent non-replicating rotavirus vaccine (t-NRRV) candidate with a mock trivalent Sabin inactivated polio vaccine (t-sIPV). Both t-sIPV and t-NRRV are incompatible with thimerosal (TH), a preservative commonly used in pediatric pentavalent combination vaccines (DTwP-Hib-HepB) distributed in low- and middle-income countries (LMICs), preventing the development of a heptavalent combination. The compatibility of t-NRRV with a mock DTwP-Hib-HepB formulation is described in a companion paper.
View Article and Find Full Text PDFDigitally Enabled Generic Analytical Framework Accelerating the Pace of Liquid Chromatography Method Development for Vaccine Adjuvant Formulations.
ACS Pharmacol Transl Sci
October 2024
Analytical Research and Development, MRL, Merck & Co., Inc., 126 E. Lincoln Avenue, Rahway, New Jersey 07065, United States.
The growing use of adjuvants in the fast-paced formulation of new vaccines has created an unprecedented need for meaningful analytical assays that deliver reliable quantitative data from complex adjuvant and adjuvant-antigen mixtures. Due to their complex chemical and physical properties, method development for the separation of vaccine adjuvants is considered a highly challenging and laborious task. Reversed-phase liquid chromatography (RPLC) is among the most important tests in the (bio)pharmaceutical industry for release and stability indicating measurements including adjuvant content, identity, and purity profile.
View Article and Find Full Text PDFStability-indicating RP-HPLC method development and validation for the quantification of amlodipine besylate and valsartan tablets in solid oral dosage form.
Biomed Chromatogr
December 2024
Stira pharmaceuticals LLC, 161, Dwight place, Fairfield, New Jersey, 07004, USA.
The present study discusses the development of simple, rapid, specific, precision, accuracy, stability indicating the HPLC method for the analysis of amlodipine besylate and valsartan tablet dosage form. The chromatographic separation was achieved using phosphate buffer with 1% triethyl amine (pH 3.0) as mobile phase-A and mixed Methanol and buffer in the ratio of (65:35)(v/v) as mobile phase-B.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!