RP-HPLC METHOD FOR ESTIMATION OF TIAPRIDE RELATED SUBSTANCE IN TABLET FORMULATION
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2015, Vol 7, Issue 11
Abstract
Objective: To develop a simple, precise, accurate related substance, reverse phase high-performance liquid chomatographic (RP-HPLC) method for the quantitative estimation of impurities which are present in dosage form of Tiapride Hydrochloride.Methods: The chomatographic separation was achieved with Inertsil C8 (250 × 4.6) mm, 5µ column with mobile phase containing a gradient mixture of 0.05 mM aqueous sodiumdihydrogen phosphate (KH2PO4)solution buffer: (with octanesulphonate and final pH of buffer was adjusted to 2.7 with Orthophosphoric acid): Acetonitrile: Methanol (800:150:50 v/v), flow rate of 1.5 ml/min and a detection wavelength of 240 nm.Results: The method exhibited linearity between range 0.125 to 1200 µg/ml, shows well resolved degradation products from Tiapride hydrochloride tablet with 0.063 µg/ml of LOD (limit of detection) and 0.125 µg/ml of LOQ (limit of Quantification). Forced degradation studies proved that the method is specific for Tiapride Hydrochloride and N-oxide Tiapride reported in European pharmacopeia and British pharmacopeia is one of the degradation impurity confirmed by liquid chromatography mass spectrometry (LC-MS) analysis.Conclusion: An accurate, precise, linear, robust and specific related substance RP-HPLC method was developed and validated for the quantitative estimation of impurities presented in pharmaceutical dosage form of Tiapride Hydrochloride as per ICH guidelines. The method is stability indicating used for separation of degradation products and can be used for the identification of process related impurity.Â
Authors and Affiliations
Jwal Doctor, Komal Chaudhary, Dharmin Joshi, Sanjay Prajapati, Priti J Mehta
Keywords
Related Articles
- EP ID EP578175
- DOI -
- Views 87
- Downloads 0
DURATION DEPENDENT ANTIAPOPTOTIC EFFICACY OF CAMELLIA SINENSIS (GREEN TEA) ON STREPTOZOTOCIN INDUCED DIABETES LINKED TESTICULAR HYPOFUNCTION IN ALBINO RAT: GENOMIC AND FLOW CYTOMETRIC ASSESSMENT
Objective: The study has been conducted to search out the threshold duration of treatment of ethyl acetate fraction of methanolic extract of leaves of Camellia sinensis (L.) Kuntze at the dose of 100 mg/kg body weight fo...
DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF PIPERAQUINE PHOSPHATE AND DIHYDROARTEMISININ IN BULK
High Performance Liquid Chromatography (HPLC) methods are described for determination of drugs as a single or in combination in bulk or pharmaceutical formulation. The objective of the present study was to develop and va...
ASSESSMENT OF KIDNEY FUNCTION, ESTIMATED GLOMERULAR FILTRATION RATE AND BODY MASS INDEX IN HIV SEROPOSITIVE SUBJECTS ON ANTIRETROVIRAL THERAPY IN NNEWI
Objective: Antiretroviral therapy (ART) is anticipated to result in an increase in long-term survival in human immunodeficiency virus (HIV) infected individuals, but may present with the development of associated complic...
ISOLATION AND SCREENING OF MARINE MICROALGAE CHLORELLA SP. _PR1 FOR ANTICANCER ACTIVITY
Objective: The objective of the present study includes isolation, characterization and screening of anticancerous activity against B16F10 cell line using isolated marine microalgae Chlorella sp._PR1.Methods: In this stud...
PHARMACOGNOSTIC STUDIES AND HPTLC FINGERPRINTING OF BLUMEA ERIANTHA DC (ASTERACEAE) LEAVES
Objective: To study the pharamacognostic, morphological, microscopical characters of leaves of Blumea eriantha DC also to carry out the chemical analysis of its leaf powder and establish the chromatographic fingerprint.M...