( ISSN 2277 - 9809 (online) ISSN 2348 - 9359 (Print) ) New DOI : 10.32804/IRJMSH

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DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE ESTIMATION OF BREXPIPRAZOLE IN BULK AND TABLET

    3 Author(s):  KHADKE A.R, KUMBHAR S.T., KATMORE P. K.

Vol -  13, Issue- 1 ,         Page(s) : 11 - 18  (2022 ) DOI : https://doi.org/10.32804/IRJMSH

Abstract

The purpose of this analysis study is to develop a novel, simple, accurate, precise, specific and economical method for RP-HPLC to determination of the connected substances in tablet and bulk form of brexpiprazole. Agilent zorbax bonus-RPC18 (250× 4.6 mm, 5µ) column using for chromatographic separation. Sodium dihydrogen phosphate having 2.5pH adjusted with 85% O-phosphoric acid it is buffer solution. Mobile part is buffer: acetonitrile (62.5:37.5 v/v) at a flow rate 1.0 ml/min. The linearity range of concentration 25-75µg/ml. 3.12min is retention time and ultraviolet detector at 215nm with 10µL injection volume. Brexpiprazole valid as per guidelines of ICH with respect of specificity, accuracy, linearity and precision. Brexpiprazole subjected with stress conditions of forced degradation (acid, oxidation, base, dry heat and UV).

Bhawar HS, Thete S, Shinde GS. Development and validation of stability indicating RP-HPLC for estimation of Brexpiprazole from bulk and tablet form. Journal of Drug Delivery and Therapeutics 2019; 9(4):141-145.
Karuna KB, Chandra Sherkar KB and Guna SV. Gradient high performance liquid chromatography method for determination of related substances in (7-{4-[4–(1-benzothiophen-4-YL] butoxy} quinoline–2[1H]-one) dosage form. Journal of Drug Delivery and Therapeutics 2019; 9(1-s):36-43.
Sowjanya B and Rambabu K. Development and validation for the simultaneous estimation of Brexpiprazole and Fluoxetine in drug substance by RP-HPLC. European Journal of Biomedical and Pharmaceutical Sciences 2018; 5(2):411-417.

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