ABSTRACT
Corona virus disease 2019 (COVID-19) has posed a mounting threat to public health with worldwide outbreak caused by a novel virus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Recently, remdesivir (RDV) has been approved by Food and Drug Administration (FDA) for treating COVID-19 patients ≥12 years old requiring hospitalization. To the best of our knowledge, a simple method to estimate RDV in the pharmaceutical formulations using high-performance liquid chromatography (HPLC) is still unexplored, highlighting the need for a precise analytical method for its quantification. The prime purpose of the current investigation was to develop and validate a well-grounded HPLC method for quantification of RDV in pharmaceutical formulations. The best chromatogram was obtained by means of an Inertsil ODS-3V column using a mobile phase of milli-Q water modified to pH 3.0 with o-phosphoric acid and acetonitrile (50:50, % v/v) at a flow rate of 1.2 mL/min and wavelength of detector set at 246 nm with retention time being achieved at 6.0 min. The method was validated following International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q2 (R1) guidelines for various parameters such as specificity and selectivity, system suitability, linearity, precision, accuracy, limits of detection and quantification, and robustness. The method developed for the quantification of RDV was found to be linear in the concentration range of 25-2,500 ng/mL with limit of detection and limit of quantification of 1.95 and 6.49 ng/mL, respectively. Assay value of 102% ± 1% was achieved for marketed injectable dosage form when estimated by the validated method. Therefore, in this study a simple, rapid, sensitive, selective, accurate, precise, and robust analytical method was developed and validated for the quantification of RDV using HPLC. The established method was successfully employed for quantification of RDV in marketed pharmaceutical formulation.
Subject(s)
Adenosine Monophosphate/analogs & derivatives , Administration, Intravenous/standards , Alanine/analogs & derivatives , Antiviral Agents/administration & dosage , Antiviral Agents/analysis , COVID-19 Drug Treatment , Adenosine Monophosphate/administration & dosage , Adenosine Monophosphate/analysis , Adenosine Monophosphate/chemistry , Administration, Intravenous/methods , Alanine/administration & dosage , Alanine/analysis , Alanine/chemistry , Antiviral Agents/chemistry , Chromatography, High Pressure Liquid/methods , Chromatography, High Pressure Liquid/standards , Dosage Forms/standards , Humans , Reproducibility of ResultsABSTRACT
With the launch of few products in the market, transdermal drug delivery through microneedles (MNs) has evidenced a major leap. Interest in MNs is growing exponentially as it overcomes the limitations accompanying other delivery routes. Among the various types of MNs, polymeric microneedles (PMNs) seem to be more propitious because of the associated favourable innate properties. Nevertheless, struggle in loading capacity, unmanageable rate of drug release, and monotonic curative approach hampers the further development of PMNs. Recent emerging research has drawn inspiration from nanocarriers and in conjunction with PMNs have opened up new perspectives for the treatment of various diseases. In this review, we focus on recent progresses in the field of transdermal drug delivery using nano carriers in conjunction with PMNs for various therapeutic and diagnostic activities. Additionally, we describe the various factors impacting drug delivery, and challenges involved in sterilization and stability aspects associated with nanocarrier loaded PMNs, highlighting future research perspectives alongside.