ORIENTAL JOURNAL OF CHEMISTRY www.orientjchem.org An International Open Access, Peer Reviewed Research Journal ISSN: 0970-020 X CODEN: OJCHEG 2019, Vol. 35, No.(6): Pg. 1805-1812 This is an Open Access article licensed under a Creative Commons license: Attribution 4.0 International (CC- BY). Published by Oriental Scientific Publishing Company © 2018 Development of Stability Indicating, Validated Liquid Chromatographic Method for Estimation of Sarecycline in its Formulations AZMATH UNISSA 1 , ANUPAMA KONERU 2 , M.MUSHRAFF ALI KHAN 3 , MURALI BALARAM VARANASI 1 and IMAM PASHA SYED 1 * 1,2,3 Department of Pharmaceutical Quality Assurance, Sultan-ul-Uloom College of Pharmacy, Mount Pleasant, #8-2-249, Road No. 3, Banjara Hills, Hyderabad-500034, Telangana, India. *Corresponding author E-mail: impazam@gmail.com, imampharmaceuticalsciences@gmail.com http://dx.doi.org/10.13005/ojc/350625 (Received: November 28, 2019; Accepted: December 29, 2019) ABSTRACT A stability indicating HPLC method was developed and for the estimation of Sarecycline Hydrochloride in tablet dosage form using C 18 column with a mobile phase composition of 0.1M Na 2 PO 4 and Acetonitrile in the ratio of 50:50 v/v . The detection wave maxima and retention time were found to 242nm and 3.876 min respectively. The method validation was carried out according to International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and the parameters namely; precision, accuracy, specificity, stability, robustness, linearity, limit of quantitation (LOQ) and limit of detection (LOD) are evaluated. The present developed RP-HPLC method shows the purity angle of peaks is less than their threshold angle, signifying that it to be suitable for stability studies. Hence, the developed method can be used for the successful estimation of Sarecycline in the pharmaceutical dosage formulations. Keywords: Sarecycline Hydrochloride, RP-HPLC, Formulation, Validation. INTRODUCTION The drug used in the present study is Sarecycline hydrochloride, chemically (4S,4a S,5aR,12aR)-4-(Dimethylamino)-1,10,11,12 a-tetrahydroxy-7-[[methoxy(methyl)amino]methyl]- 3,12-dioxo-4a,5,5a,6-tetrahydro-4H-tetracene-2- carboxamide and the structure was shown in Fig.1. It inhibits protein synthesis and other biosynthetic activities and shows anti-inflammatory action 1 . Sarecycline is a semi-synthetic derivative of tetracycline that was initially discovered by Paratek Pharmaceuticals from Boston, MA but then licensed to Warner Chilcott of Rockaway, NJ . After completing various phase-II and phase-III trials demonstrating its effectiveness in treating moderate to severe facial acne vulgaris the US Food and Drug Administration approved Barcelona based Almirall, S.A.'s Seysara (sarecylcine) as a new first in class narrow spectrum tetracycline derived oral antibiotic for the treatment