EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical, Medical & Biological Sciences

An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)

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 ISSN 2394-3211

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Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR SIMULTANEOUS DETERMINATION OF OLMESARTAN MEDOXOMIL AND CHLORTHALIDONE IN COMBINED TABLET DOSAGE FORMS

Sonali Sangle, Padmanabh Deshpande*, Neha Shinde and Vishal Tayade

ABSTRACT

The present work describes development and validation of a new simple, accurate, precise and selective stability-indicating high performance thin layer chromatographic (HPTLC) method for determination of Olmesartan medoxomil and Chlorthalidone in combined tablet dosage form. The chromatographic separation was carried out using aluminium plates precoated with silica gel 60F254 (10 × 10 cm) as stationary phase and Toluene: Ethyl acetate: Methanol (5: 3: 2, v/v/v) as mobile phase. Retention factors for Olmesartan medoxomil and Chlorthalidone were found to be 0.48±0.02 and 0.72±0.02, respectively. The wavelength selected for detection was 229 nm. Drug samples were subjected to different stress conditions like hydrolysis, oxidation, photolysis and thermal degradation. The developed method has been validated for linearity, accuracy, precision, limit of detection and limit of quantification and robustness, as per ICH guidelines. Results were found to be linear in the concentration range of 200-1200 ng band-1 for Olmesartan medoxomil and 125-750 ng band-1 for Chlorthalidone, respectively. The percentage drug contents obtained for Olmesartan medoxomil and Chlorthalidone were 99.71 and 100.45, respectively. The developed method can be used for the quantification of drugs in combined tablet dosage form as well as for routine analysis in quality control laboratories.

Keywords: Olmesartan medoxomil, Chlorthalidone, HPTLC, Stability Studies, Validation.


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Google Scholar Indian Science Publications InfoBase Index (In Process) SOCOLAR, China Research Bible, Fuchu, Tokyo. JAPAN International Society for Research activity (ISRA) Scientific Indexing Services (SIS) Polish Scholarly Bibliography Global Impact Factor (GIF) (Under Process) Universal Impact Factor International Scientific Indexing (ISI), UAE Index Copernicus CAS (A Division of American Chemical Society) USA (Under Process) Directory of Open Access Journal (DOAJ, Sweden, in process) UDLedge Science Citation Index CiteFactor Directory Of Research Journal Indexing (DRJI) Indian citation Index (ICI) Journal Index (JI, Under Process) Directory of abstract indexing for Journals (DAIJ) Open Access Journals (Under Process) Impact Factor Services For International Journals (IFSIJ) Cosmos Impact Factor Jour Informatics (Under Process) Eurasian Scientific Journal Index (ESJI) International Innovative Journal Impact Factor (IIJIF) Science Library Index, Dubai, United Arab Emirates Pubmed Database [NLM ID: 101669306] (Under Process) IP Indexing (IP Value 2.40) Web of Science Group (Under Process) Directory of Research Journals Indexing Scholar Article Journal Index (SAJI) International Scientific Indexing ( ISI ) Scope Database Academia