Review Article A REVIEW OF ANALYTICAL TECHNIQUES FOR DETERMINATION OF ANTI-HIV DRUGS RAJEEV KUMAR MISHRA 1* , NEELESH CHAUBEY 1 , JAY RAM PATEL 2 , SATISH MISHRA 3 , ROHIT SINGH 4 1 Sri Satya Sai University of Technology and Medical Science sehore M. P. India, 1 Dean Pharmacy, Sri Satya Sai University of Technology and Medical Science Sehore M. P., 2 Rungta Institute of Pharmaceutical Science and Research, Bhilai Durg C. G. India, 3 Gulabkali Memorial College of Pharmacy Chakghat Rewa M. P India, 4 Aditya College of Pharmacy Satna M. P. India Email: rajeevrewa86@gmail.com Received: 14 Jul 2020, Revised and Accepted: 23 Sep 2020 ABSTRACT Pharmaceutical analysis plays a very prominent role in quality assurance as well as quality control of bulk drugs and pharmaceutical formulations. Rapid increase in pharmaceutical industries and production of drug in various parts of the world has brought a rise in demand for new analytical techniques in the pharmaceutical industries. As a consequence, analytical method development has become the basic activity of analysis. From the times of yore, people were trying to find safe and sound ways to treat viral infections. In the current scenario, due to the emerging of new viruses, the development of drugs for their treatment is also gaining equal importance. Before launching to the market, these drugs should undergo a validation process. High-performance liquid chromatography (HPLC) coupled with ultraviolet (UV), Photodiode array detectors (PDA), Mass spectrophotometer (MS) detectors etc. is one of the fastest, safe and precise technologies used for determination and separation of pharmaceutical drugs, impurities and biological samples. HPLC is versatile and it takes less time for quantification of drugs as compared to old liquid chromatography techniques. Tenofovir disoproxil fumarate (TDF), Emtricitabine (FTC) and Efavirenz (EFV) is antiretroviral medicine used treat AIDS as well as chronic Hepatitis-B. It is used alone or with other HIV medications to help control HIV infection. The present review article assesses the published analytical methods and a variety of approach for investigation of TDF, FTC and EFV in bulk drug as well as pharmaceutical formulations including combinations. The present studies revealed that HPLC technique along with the spectroscopic have been most widely explored for the analysis. The investigatory review may provide the comprehensive details to the researchers who are working in the area of analytical research of TDF, FTC and EFV. Keywords: Pharmaceutical analysis, High-performance liquid chromatography, Tenofovir disoproxil fumarate, Emtricitabine, Efavirenz © 2020 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/) DOI: http://dx.doi.org/10.22159/ijap.2020v12i6.39040. Journal homepage: https://innovareacademics.in/journals/index.php/ijap INTRODUCTION The main goal of the pharmaceutical industry is to provide drug products with sufficient quality, efficacy and safety. The development of a new drug product and its production consist of many pharmaceutical processes, including analytical testing. The analytical data generated support further decisions on how development should be pursued or provide information on whether a drug product should be released. It is important that each such development or production process provide credible results with constant quality and therefore, it needs to be controlled and, if necessary, continually improved. By improvement of the quality of a pharmaceutical process, the quality of a drug product is also improved. Analytical methods are among the most critical processes in drug product development and production. They play a key role in supporting other development and production processes throughout all stages of a drug product’s life cycle. It is essential that an analytical method be precise, accurate and reliable, making it suitable for its intended purpose [1, 2]. In most cases, the main working principle of an analytical method is separation of the analytes present in the sample. Liquid chromatography (LC) techniques are most commonly employed, such as HPLC or ultraperformance liquid chromatography (UPLC), often in reversed- phase mode with UV absorbance detection. The purposes of analysis differ depending on the number, importance and relation of analytes that are required to be determined. Analytical methods for the assay of an active pharmaceutical ingredient (API) or determination of its related substances and degradation products are most commonly applied [2]. Development of a specific and robust stability-indicating LC method for the determination of related substances and degradation products is a complex process. It requires a deliberate forced degradation of a drug substance and/or a drug product under various stress conditions, such as hydrolytic, oxidative, photolytic, or thermal conditions, to provide stressed samples containing the analyte and its degradation products. The stress conditions are more severe than the accelerated and long-term stability conditions prescribed in the ICH guidelines for stability testing. An analytical method for determination of degradation products should be capable of detecting their increase during the product’s shelf life and the method for the assay should be capable of detecting any decrease in the drug substance’s content during its shelf life. Such methods are stability indicating [3-6]. Recent estimates indicate that 34 million people are currently living with HIV/AIDS worldwide, with approximately 2.5 million new infections occurring annually [7]. The virus is transmitted through the exchange of virus containing fluids, including blood, breast milk, semen and genital secretions [8-10]. Routes of viral infection include sexual contact, injection drug use, from mother to child during pregnancy, childbirth, or breast-feeding, and exposure of infected body fluids to exposed membranes or tissue [10, 11]. Antiretroviral therapy (ART) is the primary modality for the treatment and management of the disease and can substantially reduce HIV-related morbidity and mortality [12-14]. ART is strongly recommended for all HIV-infected individuals, regardless of pretreatment CD41 T cell count. Furthermore, ART has shown efficacy not only in disease management but also in viral prevention as pre-exposure prophylaxis in high-risk populations [15-18]. There are currently more than 25 antiretroviral (ARV) agents approved for HIV treatment by the U. S. Food and Drug Administration (FDA) in both single-and multi-drug formulations [19]. Combinatorial ART regimens are typically required for the sustained suppression of viral replication and clinical benefit [20]. Currently, more than 100 regimens exist for the treatment of HIV [21]. ARVs elicit their therapeutic effects through the targeted inhibition of various stages of the viral infection cycle. Thus, drug classes are stratified as CCR5 antagonists, viral fusion inhibitors, nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs/NtRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), integrase strand transfer inhibitors (INSTIs), and protease inhibitors (PIs). Many combinatorial ART regimens incorporate drugs from more than one ARV class, and the U. S. Department of Health and Human Services (DHHS) has indicated recommended and alternative regimens for disease management [22]. In addition, new therapies are continually International Journal of Applied Pharmaceutics ISSN- 0975-7058 Vol 12, Issue 6, 2020