I N T RO DU C T IO N A company that manufactures drug product or drug substance has a vested interest in determining the impurities associated with their compounds. The analysis of impurities can be a very labor-intensive task involving method development, impurity synthesis, isolation techniques, and various analytical approaches to determine the unambiguous identification of the impurity of i...

Abstract Background A sensitive, precise, and stability-indicating high-performance thin-layer chromatographic (HPTLC) method has been developed for the analysis of Remogliflozin etabonate in tablet formulation. HPTLC plates precoated with silica gel 60 F 254 were used as stationary phase; methanol: ethyl acetate: toluene: NH 3 (2:4:4:0.1, v/v/v) was mobile phase, densitometry quantitative esti...

(1) Background: The aim of this study was to identify the degradation product ramipril (RAM) formed under dry air and verify its potential modes carcinogenicity. We intended check whether formation presence in final dosage forms could pose a cancer risk humans who are treated with RAM due cardiological indications. carcinogenicity compound evaluated respect two mechanisms: direct DNA-damage ind...

Abstract Background A novel gradient, high-sensitive and specific stability-indicating reverse-phase HPLC method was developed validated for quantitative purpose of known, unknown degradant impurities profiling diltiazem hydrochloride tablets. The were separated on the Zorbax RX C8 column (150 mm × 4.6 mm, 5 μm) with mobile phase-A consisting a mixture 0.05 M sodium dihydrogen phosphate monohyd...

OBJECTIVE The post-reconstitution chemical stability and microbial challenge hold time of nonpreserved telavancin for injection was determined using common reconstitution diluents and intravenous (IV) infusion solutions stored at room temperature with light (ambient) or at 2°C to 8°C without light (refrigeration). METHODS Telavancin was reconstituted with 5% dextrose, 0.9% normal saline, or s...

Objective: Simple, rapid RP-HPLC and HPTLC methods have been developed in order to study the degradation of Roxadustat under various stress conditions. The Kinetics hydrolytic is studied. Methods: Optimum separation its products was achieved using following conditions HPLC, Agilent eclipse XDB-C8 (150×4.6 mm) column, mobile phase composed methanol: phosphate buffer (pH 5, 0.05 M) (70:30 v/v) wi...

Objective: The present work describes stability indicating (SI) RP-HPLC-PDA method for determination of abiraterone acetate (ABA) and characterization of its base catalyzed degradation product by LC-MS. Methods: The separation was achieved by using column Kromasil C18 Results: The retention time of ABA was 5.4±0.01 min. Linearity was found to be in the range of 5–30 μg/ml. The limit of detectio...

Abstract A systematic DoE and Analytical Quality by Design (AQbD) approach was utilized for the development validation of a novel stability indicating high-performance thin–layer chromatographic (HPTLC) method Rivaroxaban (RBN) estimation in bulk marketed formulation. D-optimal design used to screen effect solvents, volume time from spotting scanning. ANOVA results Pareto chart revealed that to...

DESCRIPTION Sevoflurane, USP, volatile liquid for inhalation, a nonflammable and nonexplosive liquid administered by vaporization, is a halogenated general inhalation anesthetic drug. Sevoflurane, USP is fluoromethyl 2,2,2,-trifluoro-1-(trifluoromethyl) ethyl ether and its structural formula is: Sevoflurane, USP, Physical Constants are: Molecular weight 200.05 Boiling point at 760 mm Hg 58.6°C ...

An accurate, simple and reproducible high-performance liquid chromatographic (HPLC) method has been developed and validated for the direct separation of individual enantiomers of Abacavir sulfate, a nucleoside reverse transcriptase inhibitor for the treatment of HIV, in pharmaceutical bulk drugs. The enantiomers were resolved by normal phase chromatography, on Chiralpak IA column by using a mob...