ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF CYAMEMAZINE TARTRATE IN FORMULATION BY RP-HPLC WITH STABILITY INDICATING

نویسندگان

چکیده

High-performance liquid chromatography (HPLC) technique for cyamemazine tartrate (CYMT) was developed and validated according to the International Conference on Harmonization (ICH) Q2 (R1) guidelines. The method estimating CYMT from a bulk its pharmaceutical dosage form found be simple, precise, accurate, fast, stable reverse phase HPLC (RP-HPLC) approach. For chromatographic separation, Hypersil BDS C18 (250 mm × 4.6 mm, particle size: 5 μm) column employed with mobile of methanol buffer (80:20 v/v) flow rate at 1.0 ml/min room temperature. detection, wavelength 270 nm utilized. With run period 10 min, eluted 4.38 min. correlation coefficient (r2) above 0.9996, limits detection quantitation (LOD LOQ) 0.27 0.80 μg, respectively, exhibited dynamic linear response across 30–90 μg/ml. repeatability batch injections intra- inter-assay precision accuracy testing likewise satisfactory. stability studied under thermal, acid, alkali, oxidation conditions, as well photodegradation conditions. approach is demonstrated by presence breakdown products. recommended great linearity, accuracy, precision, robustness, LOD, LOQ, system suitability within acceptance limit. study’s findings indicate that rapid, exact, linearly stable, implying an has been validated, it may used routine quality control analysis.

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ژورنال

عنوان ژورنال: Asian Journal of Pharmaceutical and Clinical Research

سال: 2022

ISSN: ['0974-2441', '2455-3891']

DOI: https://doi.org/10.22159/ajpcr.2022.v15i9.45154