DEVELOPMENT AND VALIDATION OF NEW STABILITY INDICATING REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS DETERMINATION OF METFORMIN HYDROCHLORIDE AND ERTUGLIFLOZIN IN BULK AND PHARMACEUTICAL DOSAGE FORM
Journal Title: Asian Journal of Pharamceutical and Clinical Research - Year 2019, Vol 12, Issue 1
Abstract
Objective: The present study deals with the development, validation, and application of simple, precise, and accurate high-performance liquid chromatography (HPLC) method for the simultaneous estimation of metformin hydrochloride and ertugliflozin in pharmaceutical formulation and to validate.Methods: The analytical conditions were optimized on BDS C8 column (150 mm × 4.6 mm, 5 μm) at room temperature. The mobile phase consists of buffer: acetonitrile in 55:45 v/v ratio. Injection volume was 10 μl. The flow rate was maintained at 1.0 ml/min, and the analysis was carried out at 224 nm.Results: The method was found to be linear in the concentration range of 125–750 μg/ml and 1.875–11.25 μg/ml for metformin hydrochloride and ertugliflozin with regression coefficient r2 = 0.999. The method was found to be precise with percentage relative standard deviation below 2%. The limit of detection and limit of quantification were found to be within the limits. The percentage recovery of the developed method was 100.15%. All the validation parameters such as robustness, recovery, and precision were found to be within the limits. Degradation parameters such as acid, base, thermal and peroxide, light, temperature, and humidity were performed and found that the drugs are stable in all the extreme conditions.Conclusions: A simple, accurate, precise, and less time-consuming reversed-phase HPLC method for the simultaneous estimation of metformin hydrochloride and ertugliflozin has been developed and validated in accordance with the ICH guidelines.
Authors and Affiliations
Venkateswara Rao P, Lakshmana Rao A, Prasad Svum
Keywords
Related Articles
- EP ID EP607134
- DOI 10.22159/ajpcr.2019.v12i1.28938
- Views 109
- Downloads 0
OSTEOMETRIC ANALYSIS OF SUPRAORBITAL FORAMEN AND NOTCH IN MALAYSIAN CRANIA
Objective: A clear knowledge of the location of supraorbital foramen (SOF) is vital for the surgeons, particularly in endoscopic surgery and regional block in crania. The aim of this study was to analyze SOF and notch in...
HISTOPATHOLOGICAL LIVER TISSUES OF ALLOXAN-INDUCED WISTAR RATS THAT GIVEN LAWSONIA INERMIS (LINN.) LEAVES’ ETHANOLIC EXTRACT
Objectives: The aim of this research was to see the effect of Lawsonia inermis (Linn.) leaves ethanolic extract (LLEE) on liver histopathological of alloxan-induced Wistar rats.Methods: Thirty-five of male Wistar rats gr...
ANTIBACTERIAL AND ANTIOXIDATION ASSAY OF THALIPATHIRI CHOORANAM PRESCRIBED TO CURE COUGH BY THE CHERUTHIKONAM TRADITIONAL SIDDHA MEDICINAL PRACTITIONER OF KANYAKUMARI DISTRICT, INDIA
AbstractThalipathiri chooranam is a polyherbal formulation prepared from 15 different herbs being used for the treatment of kapha (in Tamil) diseases. Thalipathiri chooranam, aqueous, silver nitrate and petroleum ether e...
SIMULTANEOUS DETERMINATION METHOD OF BHA, BHT, PROPYL GALLATE, AND TBHQ IN MARGARINE USING HIGH PERFORMANCE LIQUID CHROMATOGRAPHY
Antioxidants are food additives in oil and fat products usually to decrease the process of rancidity by preventing the oxidation such as in margarine. BHA, BHT, propyl gallate, and TBHQ are commonly used antioxidants. Co...
QUANTIFICATION USING ULTRAVIOLET SPECTROSCOPY METHOD AND IN VITRO STABILITY STUDY OF NANOVESICULAR SYSTEM CONTAINING PHYTIC ACID
Objective: The quantification of drug and stability of nanoparticulate delivery systems is one of the major apprehensions in biomedical applications. The present research work was attempted to quantify phytic acid by uti...