Method development and validation for multi-component analysis of lamivudine & tenofovir disoproxil fumarate in bulk drug by UV-visible spectrophotometer & RP-HPLC

A novel, simple, precise and accurate method developed for the estimation of Lamivudine and tenofovir disoproxil fumarate (TDF) in bulk drug form has been established. Lamivudine and tenofovir are well known drugs and used in treatment of HIV- Ⅰ. The method was performed by using   C18 column, ODS Hypersil column with UV detection at 262nm by using Acetonitrile and water in ratio 55:45. The retention time was found to be 2.8 and 6.8 min for Lamivudine and tenofovir disoproxil fumarate (TDF). The linearity was found in range of 6- 14µg/ml for Lamivudine and 10- 50µg/ml for Tenofovir disoproxil fumarate with flow rate 1ml/min. the method was validated for linearity, accuracy, precision and robustness as per ICH guidelines. This method is suitable for simultaneous analysis for both the nucleoside analog reverse- transcriptase inhibitor

Analytical method development and validation for simultaneous estimation of mefloquine hydrochloride and artemether in bulk drug by simultaneous equation method

The purpose of the research is to establish a fast, accurate, precise, and low-cost UV-Visible spectrophotometry method for the quantitative simultaneous estimation of mefloquine hydrochloride and artemether in bulk drug. The UV-Visible method employed was a simultaneous equation method. Ethanol was used as a solvent and therefore the absorption maxima (λ max) was found to be 229 nm and 209 nm for mefloquine hydrochloride and artemether. The linearity ranges of both drugs were 1-6 μg/mL and 100 – 350 μg/mL with a regression coefficient r2 ≥ 0.998 respectively. The method was validated for different parameters according to International Conference on Harmonization ICH Q2B guidelines. The average recovery for mefloquine hydrochloride was found to be 100 per cent and artemether 99.3 per cent. The method was also found precise and robust with a per cent relative standard deviation of less than 2. All the parameters result obtained within the limits. Therefore, the proposed method for the accurate quantitation of mefloquine hydrochloride and artemether in the bulk drug was successfully implemented

Development and validation of novel method for simultaneous estimation of Atovaquone and Mefloquine hydrochloride in bulk drug using RP-HPLC

Atovaquone and Mefloquine hydrochloride are well known anti-malarial drugs. Literature survey reveals that there was no method available for the selected drug combination. In this way, here an endeavour has been made to develop simple, precise, fast method for simultaneous estimation of atovaquone and mefloquine hydrochloride in bulk drug by using RP-HPLC method. The method was carried out by using gradient HPLC on C18 column using Shimadzu prominence LC 20 AD and mobile phase comprised of Methanol:ACN:Water in the ratio of 85:7.5:7.5 (pH 2.9 was adjusted with OPA). The method was performed with 10µl injection volume. The UV detection was done at 231nm.The retention times of atovaquone and mefloquine hydrochloride were 7.6 and 2.6 min respectively.  The proposed method was validated according to ICH guidelines. The validation parameters were linearity, accuracy, precision (inter-day, intra-day and repeatability) and robustness etc. Linearity was in the range of 80-120µg/ml for atovaquone and 40-60µg/ml for mefloquine hydrochloride. The percent recoveries of both drugs were 99.99-100% and 92.05-99.09%. This method is suitable for the routine analysis of atovaquone and mefloquine hydrochloride in bulk drugs either individually or in mixtur

Method Development and Validation for Multicomponent Analysis of Rosuvastatin Calcium and Losartan Potassium in Bulk Drug by RP-HPLC

A simple, sensitive and specific liquid chromatographic method was developed for the simultaneous estimation of Rosuvastatin calcium and Losartan potassium in bulk form. Chromatographic conditions included the  Column C-18 (Shim-pack) 250 x 4.6 mm, particle size 5 µm , mobile phase acetonitrile,  methanol and water pH 3 (orthophosphoric acid) in the ratio 20:25:55 recorded  at 233 nm. The retention time were found to be   3.55 and 4.64 min and average percentage recovery 99.42% and 99.63% for Rosuvastatin calcium and Losartan potassium respectively. The proposed method was found to comply with ICH guidelines. Keyword: Rosuvastatin calcium, Losartan potassium, RP-HPLC, accuracy and linearity

Method development and validation for simultaneous estimation of methotrexate and curcumin in Bulk Drug by using RP-HPLC

Curcumin is the natural herb that shows effect in the treatment of cancer and rheumatoid arthritis and methotrexate is well known anticancer and anti-rheumatoid drug. Literature survey reveals that there was no method available for the selected drug combination. So, here an attempt has been made to develop simple, rapid and economic method for simultaneous estimation of methotrexate and curcumin in bulk drug by using RP-HPLC method. The percentage assay from optimized method was found to be 99.68% and 99.76% for methotrexate and curcumin respectively.  The proposed method was validated for  linearity, accuracy, precision and robustness according to ICH guidelines and were found to be   within the standard range. Keywords: RP- HPLC, methotrexate, Linearity, anticance

Method Development and Validation for Multicomponent Analysis of Emtricitabine and Ritonavir in Bulk Drug by RP-HPLC

A simple, sensitive, economic and specific reverse phase liquid chromatographic method was developed for the simultaneous estimation of Emtricitabine and Ritonavir in bulk drug. Chromatographic conditions consisted of   C-18 Column (Shim-pack) 250 x 4.6 mm, particle size 5 µm , mobile phase combination of methanol and water (80:20), flow rate 1ml per minutes, run time 15 minutes and UV detection at 251nm. . The retention time for Emtricitabine and Ritonavir were found to be   3.25 and 7.8 min and average percentage recoveries 99.42% and 99.63% respectively. The validation parameters were found to comply with ICH guidelines. These methods can be further employed in future for the routine determination of Emtricitabine and Ritonavir in bulk drug and formulation. Keyword: Emtricitabine, Ritonavir, RP-HPLC, accuracy and linearity

Modern Trends in Analytical Techniques for Method Development and Validation of Pharmaceuticals: A Review

The process of drug development requires a suitable technique which helps the scientist to analyze the drug molecule is an accurate, precise, and easiest way. For the quantitative and qualitative estimation of drugs in analytical chemistry it is very important to identify the best method for method development.  This study helps the author to understand the various analytical techniques available for the process of drug development which includes spectroscopy, chromatography, electrochemical techniques, electrophoretic, flow injection analysis, and hyphenated technique. All these methods contain different analytical process with a variety of separate techniques. Also, we discuss about the modern trend which are available, and implacable in all these methods to improve the analytical behavior of these techniques. In method development process the validation of document must be required in the form of accuracy, precision, specificity, limit of detection, linearity, and range is considered. So, this review article contains the brief summary of available analytical techniques, and the latest trend in method development, or the process of method validation, and development of method. The discussed methods in this review article were revealed by the scientist, and these techniques must require in new drug development process, which helps the person to utilize the potential of these techniques. Trend in the analytical chemistry to overcome the error in method development was necessary, and the latest trends in method development technique were useful to defeat errors in analytical techniques. Keywords: Analytical techniques, Modern trends, Process of method development, and validation

Formulation and Evaluation of Microsponges Gel of Havan Ash for the Treatment of Acne

The aim of this study was to develop the Microsponges containing Havan ash composed gel formulation for the treatment of Acne. Therefore, the topical formulation containing microsponges of Havan Ash will be formulated and evaluated. The preliminary investigation was carried out for the formulation of Havan ash loaded Microsponges by using quasi emulsion solvent diffusion method (MSF1-MSF6). In the preformulation studies of Havan ash the physical description and organoleptic properties, pH, acid insoluble ash, water-soluble ash, IR spectroscopy, identification test, rheological study, atomic absorption spectroscopy is also carried out. On the basis of particle size analysis of Microsponges, percentage yield formulation MSF5 containing Microsponges formula was selected for composition of topical gel formulation. Thus the different gel base formulation (G1-G3) using Carbopol-934 (1,1.5,2.0%) was prepared by emulsification method. By considering all the relevant, physicochemical parameters, G2 gel base was selected for further loading of Havan ash containing Microsponges. The MSF5 formulation was loaded into the selected gel base G2 (1.5%). Then the formulation and evaluation of Havan ash microsponges loaded gel was done. The formulation F3 has better results than other 4 formulations. F3 have its appearance silver colour, consistency very good, Grittiness –ve, homogeneity good, wash ability very good, pH 6.3, Spreadabilty (g.cm/sec) 14.4 ± 0.77 7and viscosity (cps) 18251 ± 50.12, have good result of psychometric analysis. With the revealed results by different evaluation parameters, it is concluded that microsponges drug delivery system has become highly competitive and rapidly evolving technology and more research are carrying out to optimize cost-effectiveness and efficacy of the therapy. Keywords: Havan ash, Antimicrobial, Microsponges, Acne vulgaris, Topical gel

Advancement of Near Infrared techniques in diagnosis and treatment of cancer

Near-Infrared photoimmunotheraphy (NIR-PIT) is newly developed therapy for cancer treatment, by using a specific monoclonal antibody (mAb) conjugated to a photoactive agent i.e. IRDye 700DX. In this technique, the conjugate of specific monoclonal antibody - photoactive agent is administered intravenously to cancer patient. When NIR light is applied, the monoclonal antibody - photoactive agent conjugate (APC) is excited and selectively kill the cancer cell without harming neighbouring normal cell. NIR light alters the chemical structure of APC and damages the cancer cell membrane. For the diagnosis of tumor, it is possible to observe the movements of erythrocyte in tissues by using diffuse correlation spectroscopy (DCS). DCS flow measurements are carried out by observing photon speckle variations induced by moving tissue scattering. Another diagnostic tool is Near-infrared spectroscopy (NIRS), which is based on endogenous chromophores difference between healthy tissue and cancer by using diagnostic indicator i.e. oxy-haemoglobin or deoxyhaemoglobin, lipid or water bands. NIRS is being used in a variety of biological and pharmaceutical research fields, including brain imaging, cardiovascular radiology, formulation and quality/process control, and even clinical trial. In this review article, we describe the Near-Infrared photoimmunotheraphy (NIR-PIT) with its mechanism, role of DCS & NIRS in cancer diagnosis and various application of NIR-PIT. Keyword: Near-infrared immunotherapy (NIR-PIT); diffuse correlation spectroscopy (DCS); Near-infrared spectroscopy (NIRS); Cancer treatment; Cancer diagnosis. &nbsp