IJPAR JOURNAL https://ijpar.com/ijpar ijpar Prof.Dr.N.Sriram en-US IJPAR JOURNAL 2320-2831 A Study On Method Development And Validation For The Estimation Of Anti T.B Drugs In Oral Dosage Form By Rp- Hplc1 https://ijpar.com/ijpar/article/view/754 <p>The pharmaceutical analysis defined as “the branch of practical chemistry which deals with the resolution, separation, identification, determination and purification of a given sample of a medicine, the detection and estimation of impurities, which may be present in drug substance (or) given sample of medicine”. Chronological order of the events that are the most notable in the development of the present state of the field. Since the various types of chromatography (liquid, gas, paper, thin-layer, ion exchange, supercritical fluid, and electrophoresis) have many features in common, they must all be considered in development of the field. Analytical method development and method validation was performed for RP-HPLC method for the Isoniazid and Rifampicin in tablet formulation as per ICH norms for the following parameters: system suitability, linearity and precision (repeatability), intermediate precision (ruggedness), specificity and accuracy. From the results obtained, it was observed that the developed method was proven to be specific, precise, linear, accurate, rugged and robust and is suitable for its intended purpose.</p> Mekala Sunil Ch.Anusha Ch.Teja Bhagyaraju G.Triveni I.Anusha K.Thiruala Prasanna Reddy M.Neelima Copyright (c) 2024 2024-04-23 2024-04-23 13 2 116 125 RP-HPLC Method Development Validation And Degradation Studies For Combined Tablet Dosage-Form Of Saxagliptin & Dapaglifozin https://ijpar.com/ijpar/article/view/755 <p>A new simple, rapid, economical reverse phase high performance liquid chromatographic method was developed for the determination of Dapagliflozin and Saxagliptin in bulk and dosage-form. The separation was carried out by using column as Hypersil ODS-C18 (250mm×4.6 mm i.d.2.5µm), mobile phase Methanol: Acetonitrile: acetate buffer (pH of4.0)40:40:20 v/v, at a flow rate of 1.0ml/min, diluent as 80:20v/v mixture of water &amp; methanol used. The detection was made by UV-Vis. Spectrophotometer at 228nm. The retention times were 2.314min for Dapagliflozin and 2.904min for Saxagliptin. Calibration curve was linear over the concentration range of 2.04 to 12.05μg/ml for Dapagliflozin and 1.06 to 6.10μg/ml for Saxagliptin, mean recoveries obtained for Dapagliflozin and saxagliptin were 99.89-100.37% and 100.37-100.83% respectively, limit of detection and limit of quantification were found to be 0.257 &amp; 0.780µg/ml and 0.439 &amp; 1.33µg/ml respectively. The propose method was validated as per the ICH guidelines parameters. The method was accurate, precise, specific and rapid found to be suitable for the quantitative analysis of the drug in the combined dosage form.</p> Ravikumar Vejendla Suraj kumar labh T.Naveena Ch.Pallavi T.Anjali Syeda Jabeen. Shaikh Mohammed Aaiyas Copyright (c) 2024 2024-04-24 2024-04-24 13 2 126 134 Pharmacognostical And Pharmacological Evaluation Of Stem Bark Of Commiphora Berryi (Arn) Engl https://ijpar.com/ijpar/article/view/756 <p>The present thesis deals with the exploration of Pharmacognostical and Pharmacological Evaluation of Stem Bark of <em>Commiphora berryi </em>(Arn) Engl, which is traditionally used by the local people in South India for the treatment of ulcer. The total methanol extract was used instead of isolated compounds, since in Ayurvedic and Herbal medicine practice, the total extract is used as therapeutic agent instead of isolated compounds on the scientific approach that certain components in the extract nullify the side effects of other components. In preliminary phytochemical analysis, the methanol extract of <em>Commiphora berryi </em>(MECB) showed the presence of phytoconstituents such as carbohydrates, gum, mucilage, phytosterols, tannins, phenolic compounds and triterpenoids. The MECB was subjected to column chromatography for the separation of its phytoconstituents. The fractions obtained from column chromatography were subjected to gas chromatography coupled with mass spectrometry (GC-MS). Acute oral toxicity study of MECB was conducted as per OECD-423 guidelines and it showed no mortality or acute toxicity up to 3 g/kg, b. wt. by oral dose. Antiulcer activity of MECB was studied by aspirin plus pylorus ligation and stress induced ulcer models in rats. In aspirin plus pylorus ligation model, when compared with ranitidine treated group, the group treated with 500 mg/kg extract showed marginal activity and the group treated with 750 mg/kg extract showed significant activity, which was higher than that of the ranitidine treated group. MECB was tested for the hepatoprotective and antioxidant activity induced by carbon tetrachloride in rats at the dose of 100 mg/kg and 200 mg/kg and standard drug, silymarin at 25 mg/kg. The potential of MECB on liver markers and antioxidant liver enzymes was measured. The MECB and silymarin exhibited significant hepatoprotective effect by reducing &nbsp;the &nbsp;amount &nbsp;of &nbsp;serum &nbsp;enzymes, &nbsp;bilirubin. In antioxidant system, the liver enzyme level of SOD, CAT and glutathione peroxidase increased in a dose dependent manner. The above results reveal that the hepatoprotective effect of MECB may be due to its antioxidant and free radical scavenging properties.</p> D. Varshitha R Roshny K Sravani M Anjali Ch Manasa Bindhu R.Kavya G.Shruthi Copyright (c) 2024 2024-05-03 2024-05-03 13 2 135 145 A Review On Non Aqueous Titrations Used In Assay Of Various Drugs https://ijpar.com/ijpar/article/view/757 <p>Various titrimetric methods are available for estimation of acids and bases, except very weak acids and bases which can only be estimated by non-aqueous methods of titration or potentiometry. Non aqueous means of titrimetric analysis involves the conversion of weak acid to strong acid or weak base to strong base by excerting the differentiating effect when dissolved in basic or acidic solvents.The Non aqueous titration method was carried out using 0.1 N Perchloric acid.The end point of the titrations is determined via non aqueous indicator solutions such as crystal violet, nile blue A, 1-Naptholbenzein, oracet blue B.</p> A. Raja Reddy B. Uma Reddy A. Swarna Mahalaxmi Copyright (c) 2024 2024-05-08 2024-05-08 13 2 146 153 Formulation and invitro evaluation of phenytoin orally disintegrating tablet by using direct compression method https://ijpar.com/ijpar/article/view/758 <p>An Orally disintegrating tablet disperses readily in saliva and the drug is available in solution or suspension form for the immediate absorption and resulting in rapid onset of action. In the present research work Phenytoin Oral disintegrating tablets were prepared by Direct Compression Technique using varying concentrations of Lycoat, Croscarmellose sodium and Ludiflash as super disintegrants. The formulations prepared were evaluated for precompression &amp; post compression parameters. Form the drug excipient compatibility studies we observe that there are no interactions between the pure drug (Phenytoin) and optimized formulation (Phenytoin+ excipients) which indicates there are no physical changes. Post compression parameters was found to be within the limits. Among the formulation prepared the tablet containing concentration of Ludiflash shows 98.85±1.46% of the drug release within 60 min &amp; follows first order kinetics. The overall result indicated that the formulation F12 containing Ludiflash is better and fulfilling of the needs of the Orally disintegrating tablet.</p> K. Shobana A. Punitha Copyright (c) 2024 2024-05-08 2024-05-08 13 2 146 156 Generic Pharmaceuticals Drug Registration Requirements and Technical Data Comparison Between all GCC Countries https://ijpar.com/ijpar/article/view/759 <p>The Marketing Authorization Holder (MAH) is required to integrate technical specifications and various other documents about new pharmaceutical products to market them in different GCC countries. This research delves into the specific registration documentation necessary for the approval process of generic drugs in GCC (Gulf Cooperation Council) Countries. Each product must adhere to the distinct guidelines of the respective country it is seeking approval. The study focuses on the "Regulatory Guidelines for Generic Products Registration in GCC countries." Adhering to the guidance and regulations set forth by authoritative bodies such as the FDA (Food and Drug Administration), ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use), and WHO (World Health Organization) streamline the filing process for pharmaceuticals in GCC countries, ensuring efficiency and accuracy. In the dynamic landscape of pharmaceutical generics, this research endeavors to elucidate the disparities in registration document requirements among GCC countries, particularly through the Common Technical Document (CTD) format. By delineating these discrepancies, stakeholders can better navigate the details of regulatory compliance and streamline the process of bringing generic pharmaceuticals to market in GCC countries</p> Azharuddin Iftekhar Ahmed Amjadkhan A. Pathan Copyright (c) 2024 2024-05-08 2024-05-08 13 2 165 172 A Review On Complexometric Titrations Used In Assay Of Various Drugs https://ijpar.com/ijpar/article/view/760 <p>Utilising complex-forming processes, complexometric titrations, also known as chelatometry, are a method for determining metal ions. In this kind of volumetric analysis, the formation of a coloured complex indicates the titration endpoint. The interaction between the metal ion and ligand, which leads to the creation of a complex, is the main idea in various types of titrations. The resultant compound is stable and dissolves in water. The complexometeric titrations use a variety of indicators, including Solochrome black T, Eriochrome black T, Mordant black II, Murexide, and Cathechol violet. This method of titrations can be used to measure the hardness of the water as well as the amounts of calcium, magnesium, zinc, and copper ions in the sample.&nbsp; Complexometric titrations are frequently used to measure a mixture of many metal ions in solution.</p> A. Raja Reddy J. Sushma R. Rani Copyright (c) 2024 2024-05-16 2024-05-16 13 2 173 179 Rp-Hplc Method Development And Validation For Estimation Of Thiocolchicoside And Aceclofenac In Pure And Pharmaceutical Dosage Form https://ijpar.com/ijpar/article/view/761 <p>A simple, reproducible and efficient reverse phase high performance liquid chromatographic method was developed for simultaneous determination of Aceclofenac and Thiocolchicoside in pure form and marketed combined pharmaceutical dosage forms. A column having Symmetry (C18) (150mm x 4.6mm, 5µm) in isocratic mode with mobile phase containing Methanol: Phosphate Buffer (pH-3.8) (28:72% v/v) was used. The flow rate was 1.0 ml/min and effluent was monitored at 252 nm. The retention time (min) and linearity range (ppm) for Aceclofenac and Thiocolchicoside were (1.794, 3.440min) and (10-30, 10-50), respectively. The method has been validated for linearity, accuracy and precision, robustness and limit of detection and limit of quantitation. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.86µg/ml and 2.58µg/ml for Aceclofenac and 1.28µg/ml 3.84µg/ml for Thiocolchicoside respectively. The developed method was found to be accurate, precise and selective for simultaneous determination of Aceclofenac and Thiocolchicoside in tablets.</p> Tayyaba Mahtab B.Swapna Bolloju Shreshta Golla Shreeya K Indrasena Reddy Prithika Kurapati Gudupalli Susanya Copyright (c) 2024 2024-05-24 2024-05-24 13 2 180 190 Method development and validation for simultaneous estimation of nirmatrelvir and ritonavir by using rp hplc https://ijpar.com/ijpar/article/view/763 <p>For the simultaneous estimate of nimatrelvir and ritonavir in a pharmaceutical dose form, a straightforward, precise, and accurate approach was created. Using a typical Agilent C18 column (150 x 4.6 mm, 5), the chromatogram was conducted. The mobile phase was pumped through the column at a flow rate of 0.8 ml/min, comprising a 60:40 ratio of Acetonitrile to Buffer 0.01N KH2PO4 (2.2 pH). This approach employed 0.01N KH2PO4 as a buffer. The 30-degree Celsius mark was kept constant. The chosen optimum wavelength was 265 nm. Ritonavir and Nirmatrelvir were shown to have retention times of 2.816 and 2.241 minutes, respectively. It was discovered that Ritonavir and Nirmatrelvir had percentage RSDs of 0.6% and 0.4%, respectively. 99.15% and 99.77% of the patients recovered from nirmatrelvir and ritanavir, respectively. Regression models for Nirmatrelvir and Ritonavir yielded LOD and LOQ values of 0.21 and 0.16 and 0.65 and 0.48, respectively. Nirmatrelvir's regression equation is y = 16802x + 995.5, while Ritonavir's is y = 16802x + 995.5. The devised method was found to be straightforward and cost-effective due to the reduction of both the retention times and run time. Industries can use this approach for routine quality control testing.</p> P. Sri Jyothi A. Sowjanya Aishwarya Bhendekar Emmannial kareti Copyright (c) 2024 2024-05-28 2024-05-28 13 2 191 223 Pharmacognostical Standardization and Phenetics of Ziziphus oenoplia (L.) Mill leaves https://ijpar.com/ijpar/article/view/764 <p><em>Ziziphus oenoplia</em> (L.) Mill is medicinal herb, belongs to the family (Rhamnaceae), commonly known as jackal jujube. The plant is used in traditional system of Indian and Thailand medicine for treatment of uterus inflammation, anthelmintic, spermatorrhoea, healing of cuts and boils. The literature look over revealed that the plant showed the presence of flavanoids, phenols, alkaloids, glycosides, pentacyclic triterpenes, carboxylic acids, aromatic compounds, nitro compounds, and esters. The plant exhibits antibacterial, antimicrobial, wound healing, anthelmintic, antioxidant, hepatoprotectivce, antiplasmodial, anticancer, antinociceptive and antidiarrhoeal activity. The fresh leaves of <em>Ziziphus oenoplia</em> were authenticated, collected, shade dried and coarsely powdered, was extracted with hydroalcohol. The extract was concentrated and stored in air tight container for further use. The present study was aimed to investigate the pharmacognostical, physic-chemical standardization and phenetics of the leaves of <em>Ziziphus oenoplia</em>.</p> A. Krishnaveni V. Manju Shree D. Dodi T. Venkata Rathina Kumar Copyright (c) 2024 2024-05-29 2024-05-29 13 2 224 234 Pharmacognostical and phenetics assessment of Pandanus amaryllifolius https://ijpar.com/ijpar/article/view/767 <p><em>Pandanus amaryllifolius</em>, an aromatic tropical plant belongs to Pandanaceae, Taiwanese used the plant and its preparations to treat fever, severe jaundice, smallpox, headaches, arthritis and dental problem. Essential oil obtained from the leaf is used as a stimulant, antispasmodic is effective against headaches, rheumatism, epilepsy, sore throat, diabetes, diuretics and for skin diseases. It exhibited antiviral, antioxidant, antihyperglycemia, anticancer, antimicrobial activities. The present research papers assigns with macroscopic, microscopic of <em>Pandanus amaryllifolius </em>leaf along with phenetics are also studied.</p> A.Krishnaveni D. Dodi V. Manju Shree T. Venkata Rathina Kumar Copyright (c) 2024 2024-06-04 2024-06-04 13 2 235 244