IJPAR JOURNAL

A Comprehensive Review On Analytical Methods For The Quantification Of Favipiravir In The Drug Product, Drug Substance And In Biological Samples

V. Sravan Kumar — 2024-01-03

Advanced Pharmaceutical analysis plays an important role in the quantitative estimation of drugs in the drug formulations and in biological samples. The Present review highlights the different methods used for the estimation of Favipiravir. Favipiravir is one of the drug used in the management of COVID-19 infection. Favipiravir acts by selectively inhibiting the RNA dependent RNA polymerase, an enzyme required for RNA viral replication inside human cells. It shows a broad spectrum of activity against different RNA viruses including influenza virus. The current review article provides the data for the quantification of favipiravir by using UV, HPLC and LCMS/MS methods. In this review the estimation of favipiravir in the drug substance and product can be done by using HPLC methods and in the plasma sample the drug quantification can be done by using LC MS/MS methods. This data can be used for the verification of listed methods briefly for the development of new methods for the research and development

Development And Validation For The Simultaneous Estimation Of Fluticasone And Vilanterol In Bulk Form And In Its Pharmaceutical Dosage Form By Using RP-HPLC Method

N. Subhashini — 2024-01-03

A new, simple, rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validation of Fluticasone and Vilanterol in its pure form as well as in combined marketed formulation. Chromatography was carried out on a Phenomenex Luna C18 (4.6mm×250mm) 5µm particle size column using a mixture of Methanol: Phosphate Buffer (pH-4.2) (37:63% v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 275nm. The retention time of the Fluticasone and Vilanterol was found to be was 2.133, 3.692 ± 0.02min respectively. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The method produce linear responses in the concentration range of 20-60mg/ml of Fluticasone and 10-30mg/ml of Vilanterol. The inter-day and intra-day precisions were found to be within limits. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations

Physicochemical Evaluation and Pharmacognostic Study of Panibel (Ampelocissus latifolia) (Roxb.) -Stem

Asmita Soni — 2024-02-07

Ampelocissus latifolia, belonging to the Vitaceae family, is a climber plant, mostly found in the Sub-Himalayan region of India, ranging from the Sutlej eastward to Kumaon up to 4000 feet, as well as in Aasam, Konkan, Western Ghats from Bombay to Nilgiris and Anamallis Deccan. Various parts of this plant is using to treatment of the several human diseases like leaf and stem bark is useful for wound healing, whole plant is used Kustha (leprosy) and Sotha (swelling).The stem bark is used in stomach pain and bone fracture. The roots are used in skin diseases, wound healing, rheumatic affections, fractures, diuretic, gonorrhoea, syphillis, eye diseases, menstrual troubles and also as a tonic. Ethno-medicinal and therapeutic uses of Ampelocissus latifolia various parts study was undertaken. In present investigation various tools and techniques included like that pharmacognostic studies, physicochemical tests, preliminary phytochemical analysis and development of HPTLC fingerprints profile. The established parameters can be used as standards for further study and also preparation of a monograph of Ampelocissus latifolia plant stem.

Validated Rp-Hplc Method For Simultaneous Estimation Of Torsemide And Spironolactone In Bulk And Tablet Dosage Form.

Megharaj Lavanya — 2024-02-13

Background: A simple, accurate and precise HPLC method for simultaneous determination of Spironolactone and Torsemide in pure and tablet dosage form has been developed. Aim: To develop and validate analytical method for simultaneous estimation of Spironolactone and Torsemide in pharmaceutical formulation by RP-HPLC.

Materials and Methods: HPLC of Waters (Model: Alliance 2695) with Phenomenex Luna C18 (4.6 mm I.D. × 250 mm, 5 µm) column was used for chromatographic separation. It contains waters injector and PDA Detector (Deuterium). Mobile phase consists of Methanol:Water (65:35% v/v) and flow rate adjusted was 1ml/min. Wavelength selected for detection was 220nm and injection volume was 10 µl. Results and discussion: By using the developed method, retention time of Spironolactone and Torsemide was found to be 3.2min and 5.4min respectively. The method has been validated for linearity, accuracy and precision. Linearity of Spironolactone and Torsemide were in the range of 75–375μg/ml and 15–75μg/ml respectively. The percentage recoveries obtained for Spironolactone and Torsemide were found to be in range of 99.3 – 99.6%. LOD and LOQ were found to be 12.5µg/ml and 38.1µg/ml for Spironolactone 3.7and 11.4µg/ml for Torsemide. Conclusion: The developed HPLC method offers several advantages such as rapidity, usage of simple mobile phase and easy sample preparation steps. Further, improved sensitivity makes it specific and reliable for its intended use. Hence, this method can be applied for the analysis of pure drug and pharmaceutical dosage forms. From the present study it can be concluded that the proposed method is simple, sensitive, precise, specific, accurate and reproducible. Results of validation parameters demonstrated that the analytical procedure is suitable for its intended purpose and meets the criteria defined in ICH Q2R1.

Formulation and in vitro characterisation of milnacipran hydrochloride orodispersible tablets

Muthyala Amarender Goud — 2024-02-13

Present study is aimed at the development of oral dispersible tablets of Milnacipran Hydrochloride using natural superdisintegrants. Indion 414, Polyplasdone XL 10, Primogel for the preparation of oraldispersible tablets by direct compression method. The blends were evaluated for the pre-compression parameters and all the formulations were found to possess good flow properties. Tablets were compressed by direct compression technique, evaluated for weight variation, hardness, thickness, friability, water absorption, disintegration time, dispersion time drug content and dissolution studies. The drug release profiles of the three superdisintegrants were compared. The optimized formulation F2 was showed good results disintegrated in 3.15 min with 98.89 % drug release.

Quantitative Estimation Of Sofosbuvir And Velpatasvir In Tablet Dosage Forms By Rp-Hplc Method

Kotari Abhishek — 2024-02-13

A rapid and precise Reverse Phase High Performance Liquid Chromatographic method has been developed for the validated of Sofosbuvir and Velpatasvir, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Symmetry C18 (4.6 x 150mm, 5µm) column using a mixture of Methanol: TEA pH 4.2 (40:60) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 272 nm. The retention time of the Sofosbuvir and Velpatasvir was 2.781, 4.048 ±0.02min respectively. The method produce linear responses in the concentration range of 7.5-37.5µg/ml of Sofosbuvir and 5-25µg/ml of Velpatasvir. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.

Formulation And Evaluation Of Floating Microspheres Of Repaglinide By Ionic Gelation Method

Sirsinigandla Bindu Sri — 2024-02-22

The objective of the present study was to Prepare the alginate microspheres of Repaglinide (model drug) using calcium chloride as a crosslinking agent by inotropic gelation method. Microspheres were prepared by using 2%, 2.2% sodium alginate concentrations. Polymers (HPMC, Ethyl cellulose, Carbopol 934P) were used in combination concentration to prepare Microspheres. Microspheres were evaluated for micromeritic properties like angle of repose, bulk density, tapped density, Carr’s index, Hausner’s ratio and for drug content. The in vitro drug release study was done for microspheres All formulations. The mean particle size, In vitro Buoyancy, Encapsulation efficiency %, Percentage yield (%) were within limits. Among all formulations of floating microspheres F7 was considered as optimised for floating microspheres. From the release kinetics data, it was evident that floating optimised formulation follows Peppas release kinetics.

Current Regulations For Herbal Products

Avusula Satish Kumar — 2024-03-20

Officinal plants and their products have great social and economic consequences, and today they are used in four principal sectors: food, cosmetics, health and medicine. The medicinal use of the herbal drugs, Phytotherapy, is differently controlled in different countries, but with only marginal differences because phytotherapeutic products must possess quality, safety and efficacy. The use of herbs as health foods, as well as food supplements, complicates the formulation of regulations by countries throughout the world. The increasing supply of herbal products to international markets makes it necessary for international organizations, such as the World Health Organization (WHO) to develop standards relative to their commercialization throughout the world. The classification of drugs varies from country to country, with active foods, dietary supplements and traditional medicines being included in certain categories. The stability of those products is also unknown and complex to the critical problem in the analysis of herbal products that this is a complex ingredient combination, as well as the elements responsible for the treatment effects. In order to identify the changes to the newly introduced regulations or regulations, detailed literary searches and online searches for herbal medicinal products regulations have been made in South-east Asia and European countries.

Solving of complex regulatory matters in the method of current practices

Konakanchi Veerendra — 2024-03-20

MHRA (Medicines And Health Products Regulatory Agency) is the regulatory authority body for pharmaceuticals approval in the UK union. MHRA is formed by the merging of two separate agencies in 2003 i.e., Medicines Control Agency and Medical Device Agency. This agency works to maintain safety, quality and efficacy of the drug product before it enters into the country. The main aim of this work is to know about the practice and the regulatory requirements for the registration of a drug in the UK as per the regulations of MHRA. They are responsible for ensuring that the medicines and medical devices are acceptably safe and don’t cause any harm to the patients. MHRA provides a license which is a marketing authorization to the manufacturer, required before a drug is being used by the patients of that country. Good Manufacturing Practice (GMP) is the minimum requirement that a manufacturer should possess during the period of production of the drug product. New drugs are being invented and also being distributed as per the needs of the patients. It is known that no drug product is completely safe or is 100% safe for use, but MHRA tries to minimize as many problems regarding the drug so that patients will be provided with the best drug with minimal risk.

Formulation Development And Evaluation Of Azilsartan Medoxomil Sustained Release Tablet

Aayushi Sharma — 2024-03-27

The purpose of the study was To design, formulate and evaluate sustained release tablets of Azilsartan Medoxomil which is expected to deliver the drug in controlled and sustained release manner with reduce frequency of drug administration, reduce GI tract side effects and improve patient compliance. The present work is aimed at preparation and evaluation of Sustained Release matrix tablets of Azilsartan Medoxomil using using HPMC, Vinyl pyrrolidone vinyl acetate as polymers in varying ratios. The tablet were evaluated for its Thickness, Hardness, Friability, Friability, Disintegration and in vitro drug release studies. The FTIR studies revealed no chemical interaction between the drug molecule and polymers and found that drug was compatible with used polymer. In vitro drug release study confirms that formulation F4 was the best formulation as it releases 98.87 % at the end of 12 hr. This confirms the developed Azilsartan Medoxomil tablet are promising for sustained release drug delivery system.