Liquid Chromatographic Method Development for Quantification of Inorganic Nitrite and Nitrate Impurities from Nitroglycerin Drug Substance by Using Ion-Pair Reagents with Liquid-Liquid Extraction Technique.

A large number of laboratory studies have reported Nitrite (NO2-) and Nitrate (NO3-) to be among the most common degradation products of the high-explosive Nitroglycerin drug substance. A novel, simple, robust and rapid reversed-phase high-performance liquid chromatography method has been developed for quantification of inorganic Nitrite and Nitrate impurities from Nitroglycerin drug substance. Successful separation was achieved in isocratic elution, using Inertsil C8-3, (250 × 4.6 mm, 5.0 µm) column, with mobile phase consisting of pH 7.0 tetrabutyl ammonium hydrogen sulfate buffer, methanol and acetonitrile (96:02:02, v/v/v). Flow rate was monitored at 2.0 mL min-1 and ultraviolet detection at 220 nm. The present work describes the role of an ion-pair reagent in the separation of polar compounds and liquid-liquid extraction technique for separation of polar and non-polar compounds. Nitroglycerin was subjected to various stress conditions to demonstrate the stability-indicating power of the method. The performance of the method was validated as per present International Council for Harmonisation (ICH) guidelines for specificity, linearity, accuracy, precision, ruggedness and robustness. The developed method can be a valuable alternative to the current ion-exchange chromatographic method mentioned in the literature. To the best of our knowledge, a rapid Liquid Chromatography (LC) method, which separates inorganic Nitrite and Nitrate impurities of Nitroglycerin, disclosed in this investigation was not published elsewhere.

Long-Acting Injectables: Current Perspectives and Future Promise.

The parenteral route of administration is preferred over the oral route for treatment of many chronic and life-threatening diseases due to better patient compliance. Long-acting injectables/depot delivery systems are formulations intended for prolonged/sustained drug release over a long period of time ranging from a few days to months. Depot delivery systems enhance product quality by decreasing dosing frequency, simplifying the drug regimen. Parenteral depots reduce the relapse rate of disease and the maintenance phase of therapy, hence improving efficacy and treatment adherence. However, despite being extensively explored in the last seventy years, only a few depot products have been marketed or have reached commercial viability. The introduction of long-acting injectables of any drug took 9 to 10 years after approval of its oral formulation. Mainly the market has been conquered by long-acting injectables for antipsychotic, substance abuse, and hormonal therapy drugs. This article focuses on the preparation of long-acting injectables with special emphasis on challenges associated with formulation. The evolution and current global market trend of various depot formulations are also discussed. Insight is provided into the promising future of long-acting injectables of protein-based drugs as well as multidrug therapy, along with potential uses in the treatment of chronic diseases like HIV, Parkinson's, and Alzheimer's.

Current approaches for in vitro drug release study of long acting parenteral formulations.

Long acting parenteral formulations are preferred over conventional formulations for the treatment of chronic diseases. Prevalence of such diseases provoked the interest of researchers and pharmaceutical industries in the development of long acting parenteral formulations. The regulatory guidelines and pharmacopoeia have remained silent on dissolution methods for long acting parenteral formulations due to their diverse nature. The lack of compendial method for dissolution testing increases the duration of approval process for long acting parenteral formulations. This article reviews various dissolution methods used to study in vitro drug release profile of long acting parenteral formulations. Compendial as well as noncompendial methods, such as- rotating dialysis cell, dialysis tube, rotating bottle, shaking flask, single drop, inverted cup and incubation, are used by researchers for drug release profile of long acting parenteral formulations. This review article also highlights the advantages and disadvantages of reported dissolution methods along with the suitability of these methods for particular type of long acting formulation. The compiled work will help the researchers in designing the biorelevant dissolution method and expedite the development of long acting parenteral formulations.

Nondestructive and rapid concurrent estimation of paracetamol and nimesulide in their combined dosage form using Raman spectroscopic technique.

A rapid, nondestructive Raman spectroscopic method was developed for quantitative estimation of paracetamol and nimesulide in their combined dosage form. A Raman univariate calibration model was developed by measuring the peak intensities of paracetamol and nimesulide at 853 cm(-1) and 1336 cm(-1), respectively. The developed method was successfully applied for in situ, concurrent estimation of paracetamol and nimesulide in their combined dosage and method was also validated according to International Conference on Harmonisation guidelines. Thus, the developed Raman spectroscopic method can be applied for simultaneous estimation of paracetamol and nimesulide in their combined dosage form as a process analytical technology tool by pharmaceutical industries for routine quality control.