Open AccessDEVELOPMENT AND VALIDATION OF A STABILITY INDICATING REVERSE PHASEHIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS DETERMINATION OF CLINDAMYCIN, METRONIDAZOLE, AND CLOTRIMAZOLE IN PHARMACEUTICAL COMBINED DOSAGE FORMS
Author(s) -
Revathi Naga Lakshmi Ponnuri,
Prahlad Pragallapati,
Sk. Mastanamma,
N. Ravindra,
Venkata Basaveswara Rao Mandava,
Borusu Sri Naga Sudha,
Koppisetti Baladurga Prasad
Publication year - 2016
Publication title -
asian journal of pharmaceutical and clinical research
Language(s) - English
Resource type - Journals
eISSN - 2455-3891
pISSN - 0974-2441
DOI - 10.22159/ajpcr.2017.v10i1.14273
Subject(s) - clotrimazole , chromatography , detection limit , analyte , chemistry , metronidazole , high performance liquid chromatography , acetonitrile , dosage form , antifungal , antibiotics , medicine , biochemistry , dermatology
Objective: The objective of present work was to develop and validate a simple, fast, precise, selective, and accurate reverse phase high-performanceliquid chromatography method for the simultaneous determination of Clindamycine, Metronidazole and Clotrimazole in a pharmaceutical dosageform.Methods: The separation of these three drugs was achieved on ODS 250×4.6 mm, 5 mm C column. Mobile phase containing 0.1% ortho phosphoricacid buffer and acetonitrile in the ratio of 55:45 v/v was pumped through column at a flow rate of 1 ml/minute. Temperature was maintained at 30°Cand ultraviolet detection at 238 nm.18Results: The retention times were observed to be 2.591, 3.584, and 4.221 minutes for Clindamycine, Metronidazole, and Clotrimazole, respectively.Linearity was found to be 25-150 μg/ml Clindamycine, Metronidazole, and Clotrimazole, respectively. The method was statistically validated forlinearity, recovery, the limit of detection (LOD), limit of quantification (LOQ), accuracy, and precision. The stress testing of the drugs individually andtheir mixture are carried out under acidic, alkaline, oxidation, photostability, and thermal degradation conditions and its degradation products arewell resolved from the analyte peaks.Conclusion: This method was successfully validated for accuracy, precision, and linearity, LOD, and LOQ.Keywords: Clindamycine, Metronidazole, Clotrimazole, Reverse phase-high performance liquid chromatography, Simultaneous determination,Degradation studies.