A NEW STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ERTUGLIFLOZIN AND SITAGLIPTIN IN BULK AND PHARMACEUTICAL DOSAGE FORM ITS VALIDATION AS PER ICH GUIDELINES
Journal Title: Indo American Journal of Pharmaceutical Sciences - Year 2018, Vol 5, Issue 4
Abstract
A new RP-HPLC method for the quantitative determination of Ertugliflozin and Sitagliptin was developed and validated as per ICH guidelines. The drugs were injected into Std Azilent column (150×4.6, 5 μm), maintained at ambient temperature and effluent monitored at 240 nm.The mobile phase consisted of Buffer (Potassium di hydrogen Ortho Phosphate): Acetonitrile (70:30 V/V). The flow rate was maintained at 1.0 ml/min. The calibration curve for Ertugliflozin and Sitagliptin were linear from 3.75-22.5μg/ml and 25-150μg/ml respectively (r2 for Ertugliflozin = 0.9992,r2 for Sitagliptin = 0.9995). Retention time was 3.203min (Ertugliflozin), 2.106min (Sitagliptin ). Accuracy was in the range of 99.67-99.90% for both drugs. Precision was 0.1% and 0.2% for Ertugliflozin and Sitagliptin, LOD and LOQ are 0.43ug/ml and 1.31ug/ml for Ertugliflozin and , 0.74ug/ml and 2.24ug/ml for Sitagliptin. The proposed method was adequate, sensitive, reproducible, accurate and precise for the determination of Ertugliflozin and Sitagliptin in bulk and pharmaceutical dosage forms. When applied for tablet assay, drug content was within 99.18.-99.13 % of labeled content. Forced degradation studies indicated the suitability of the method for stability studies. Keywords: Ertugliflozin and Sitagliptin, RP-HPLC Method, Simultaneous estimation, Validation as per ICH guidelines, Forced degradation studies.
PRELIMINARY STUDIES OF PHYTOCHEMICAL INVESTIGATION ON COASTAL MEDICINAL PLANTS OF BOLOOR, MANGALORE
The present study was aimed to screen the phytochemicals present in five different solvent extracts of Ipomoea –per caprea, Premna serratifolia and Synadenium grantii.Qualitative estimation of three coastal medicinal pla...
SEPARATION AND QUANTIFICATION OF PHARMACOLOGICALLY ACTIVE MARKERS p-METHOXY BENZOIC ACID, 3, 4-DIHYDROXYBENZOIC ACID AND GALLIC ACID FROM CAPPARIS SPINOSA AND FROM MARKETED FORMULATION BY HPTLC
A simple, accurate, precise and reproducible High Performance Thin Layer Chromatographic (HPTLC) method for simultaneous quantification of p-methoxybenzoic acid, 3, 4-dihydroxybenzoic acid and Gallic acid in the leaf ext...
A REVIEW ON THE CURRENT TRENDS IN THE RECENT DEVELOPMENT OF HPLC/UHPLC/UPLC METHODS FOR THE EVALUATION OF VARIENT IMPURITIES IN VARIOUS PHARMACEUTICAL DRUGS
New chromatography technology for the analytical laboratory is being driven by the ever expanding need and challenge to get more and better information faster, all in an economic climate where cost control is a primary c...
DEVELOPMENT AND VALIDATION OF UV-SPECTROSCOPIC METHOD FOR THE ESTIMATION OF METFORMIN IN BULK AND PHARMACEUTICAL DOSAGE FORM
A new simple, accurate, rapid, precise, reproducible and cost effective spectrophotometric method for the quantitative estimation of Metformin in bulk and pharmaceutical dosage form. The developed visible spectrophotomet...
AN EXPLORATORY REVIEW OF THE MYTHS AND COMMON BELIEFS ABOUT ACNE AND ITS TREATMENT
Objective: To assess considerations of patients about various dietary and preventive factors of acne regarding their disease and treatment Methods and Results:100 patients presenting with Acne Vulgaris to Out Patient Dep...