The use of the hollow cathode discharge source for the excitation of nonmetals In volume-limited samples is discussed. The effects of breakdown voltage, fill-gas composition, electrode composition, hollow size, sample deposition mode, current, and fill-gas pressure on the emission signal from phosphorus and chlorine are reported. Instrumentation, operation, and sample preparation procedures are described. Temporal profiles of the emission signal from very small samples deposited in the hollow are given for P, Cl, and Se. Detection limits of 9 and 20 pg are reported for P and Cl, respectively.

The objective of the current research article is to provide a comprehensive review of excipients impact on the stability of the drug product and their implications during the product development. Recent developments in the understanding of the degradation pathways further impact methodologies used in the pharmaceutical industry for potential stability assessment. The formation of drug excipient adducts was very common based on the sensitive chemical moieties in the drugs and the excipients. The formation of the impurities was not limited to drug related impurities but there were several possibilities of the drug-excipient adduct formations as well as excipient impurities reaction with Active Pharmaceutical Ingredients. Identification of drug degradation in presence of excipients/excipient impurities requires extensive knowledge and adequate analytical characterization data. Systematic literature review and understanding about the drug formulation process, give you a smooth platform in establishing the finished product in the drug market. This paper discusses mechanistic basis of known drug-excipient interactions with case studies and provides an overview of common underlying themes in solid, semisolid and parenteral dosage forms.

Excipients interactions with the drug product are the most predominant causes for a product failure. Regulated guidelines have stringent limits for the unknown impurities observed in the pharmaceutical dosage forms. The quality of the excipients plays an important role in the finished product dosage forms which will form unknown impurities due to the impurities present in the excipients. Sometimes change in excipient manufacturer/lot gives not only the formulation related inconsistencies but hard-hitting encounters to analytical research due to their interactions with the drug product and formation of unknown impurities. Flavors used in the formulation process are the most possible origins to form impurities due to the trace level presence of aldehydes and ketones that were apparently used for its aroma. In this article identification, synthesis, and characterization of unknown impurity formed in the famotidine oral solution due to benzaldehyde which is present in the excipient of cherry flavor used in the formulation process. The samples of this impurity were investigated by HPLC and ultra performance liquid chromatography (UPLC)-MS/MS to generate the mechanism of the impurity formation. The impurity was synthesized, separated, and purified by preparative HPLC and characterized by UV, MS/MS, and NMR Results.

A rapid, simple, specific and sensitive LC-MS/MS method has been developed and validated for the enantiomeric quantification of amlodipine (AML) isomers [R-amlodipine (R-AML) and S-amlodipine (S-AML)] with 200 μL of human plasma using R-AML-d4 and S-AML-d4 as corresponding internal standards as per regulatory guidelines. A simple liquid-liquid extraction process was used to extract these analytes from human plasma. The total run time was 3.5 min and the elution of R-AML, S-AML, R-AML-d4 and S-AML-d4 occurred at 1.62, 2.51, 1.63 and 2.53 min, respectively. This was achieved with a mobile phase consisting of 0.2% ammonia-acetonitrile (20:80, v/v) at a flow rate of 1 mL/min on a Chiralcel OJ RH column. A linear response function was established for the range of concentrations 0.1-10 ng/mL (r >0.998) for each enantiomer. The intra- and inter-day precision values for both enantiomers met the acceptance criteria. Both enantiomers were stable in a set of stability studies, viz. bench-top, auto-sampler, freeze-thaw cycles and long-term. The current assay was successfully applied to a pharmacokinetic study to quantitate AML enantiomers following oral administration of 10 mg AML tablet to humans.

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