International Journal of Research In Pharmaceutical Chemistry and Analysis 2021-01-09T04:46:40+00:00 The Editor Open Journal Systems <p align="justify">Rubatosis Publication has launched its scientific journal named International Journal of Research In Pharmaceutical Chemistry And Analysis (<strong>IJRPCA ISSN (Online): <u>2582-1970</u></strong>) IJRPCA will be published quarterly per year in January, April, July, and October. The journal publishes original research work that contributes significantly to further the scientific knowledge in Pharmaceutical Chemistry and Analysis.</p> Stability indicating RP-HPLC method for the estimation of flucloxacillin sodium in a tablet dosage form 2020-09-11T21:07:39+00:00 Sonalika Patro S. Harshith Kumar M. Barath kumar E. Masthaniah K. Sairam S. Prem Sumanth Kumar <p>A Simple, accurate and precise method was developed and validated for the determination of flucloxacillin sodium in its tablet dosage form. The separation was eluted on xterra c18 column (4.6x150mm, 5micron) using a mixture of octane buffer and methanol as mobile phase in a ratio of (30:70) which was pumped through column at a flow rate of&nbsp; 1ml/min. Optimised wavelength for flucloxacillin was 237nm, the retention time was 2.305minutes and the percentage purity was found to be 98.14%. System suitability parameters such as theoretical plate and tailing factor for flucloxacillin sodium was found to be 2991.64 and 1.90 respectively, the proposed method was validated as per ICH guidelines (ICH, Q2 AND (R1)) the method was found to be linear at the concentration range of 20-100µg/ml and the correlation coefficient (r2) value was found to be 0.9994 percentage RSD for precision was 0.9% and percentage RSD for ruggedness was 0.5%. The precision study was precise, robust and repeatable. The LOD and LOQ values are 2.98 and 9.98 respectively. Hence the suggested RP-HPLC method can be used for routine analysis for flucloxacillin sodium in tablet dosage form.</p> 2020-08-31T00:00:00+00:00 Copyright (c) 2020 Sonalika Patro, S. Harshith Kumar , M. Barath kumar, E. Masthaniah, K. Sairam, S. Prem Sumanth Kumar A robust stability indicating HPLC technique for evalution of Pibrentasvir and Glecaprevir in tablet dosage form 2020-09-11T21:07:37+00:00 Salomi Patta Shobha Rani P Ravindra Reddy K Afreen sultana <p align="justify">When liver cells gets infected and vandalized, the condition is termed as Hepatitis. HCV therapy is performed with mixture of drugs. For the combined evaluation of Pibrentasvir and Glecaprevir in tablets, a rapid, selective and robust HPLC technique stability indicating was developed herein this work. Analysis was executed by Cosmicsil, with dimensions 250 mm by 4.6 mm column and mobile phase possessing KH<sub>2</sub>PO<sub>4</sub> with 0.1M, 65 ml and 35 ml of methanol and 230 nm of PDA analysis. Elution times were found out as were 1.663 min and 2.249 min, for Pibrentasvir and Glecaprevir respectively with linear ranges 20µg/ml, 60 µg/ml and 50 µg/ml, 150 µg/ml, respectively having detection limits as 0.190 µg/ml and 0.207 µg/ml and quantization limits as 0.634 µg/ml and 0.690 µg/ml. This method is explicit having RSD values as 0.097% Pibrentasir &amp; 0.232% Glecaprevir showing an accuracy of between 98.82 and 100.07% for Pibrentasir 99.31, Glecaprevir 100.45% recovery values. During the investigation of degradation, peaks elution times of degradants greatly varied with the elution times of Glecaprevir and Pibrentasvir thus, proving method‘s power of stability indication and specificity. The validation and degradation stability studies were carried out according to ICH and ICH Q1B Guidelines.</p> 2020-08-31T00:00:00+00:00 Copyright (c) 2020 Salomi Patta, Shobha Rani P, Ravindra Reddy K, Afreen sultana A Photo Stability Indicating HPLC technique for Validation of Netupitant and Palonosetron in Bulk and Formulations 2020-09-12T21:27:59+00:00 Patta Salomi Bathala Sireesha Afreen sultana Ravindra Reddy <p>Analytical chemistry is the science that seeks ever improved means of measuring the chemical composition of natural and artificial materials.Netupitant Delayed emesis has been largely associated with the activation of tachykinin family neurokinin 1 receptors. Palonosetron is a selective serotonin 5-HT3 receptor antagonist. The antiemetic activity of the drug is brought about through the inhibition of 5-HT3 receptors present both centrally&nbsp; and peripherally in turn inhibits the visceral afferent stimulation of the vomiting center.The mobile phase used was orthophosphoric and acetate 70% buffer pH 3 and 30% methanol.The assay of Netupitant and Palanosetron was performed with tablets and the % assay was found to be 100.08 and 100.04, The linearity was found to be linear with a correlation coefficient of 0.999, the precision 0.8 and 0.3 for Netupitant and Palanosetron which shows that the method is precise.The validation of developed method shows that the accuracy is well within the limit, which shows that the method is capable of showing good accuracy and reproducibility. The LOD and LOQ for Netupitant were found to be 3.02 and 9.98 and LOD and LOQ for Palanosetron was found to be 3.00 and 10.00. Thus, it shows that the method is stability indicating, sensitive, accurate, robust and precise. Hence, the developed HPLC method can be successfully applied to the pharmaceutical dosage form and can be used for routine analysis.</p> <p><strong>&nbsp;</strong></p> <p>&nbsp;</p> <p>&nbsp;</p> 2020-08-31T00:00:00+00:00 Copyright (c) 2020 Patta Salomi, Bathala Sireesha, Afreen sultana, Ravindra Reddy Development and validation of UV-visible spectrophotometric method for determination of Bicalutamide in bulk and in pharmaceutical dosage form 2021-01-09T04:46:40+00:00 V. Hariharasudhan P. Divakar A. Maheswaran D. Saravanan <p>The aim of the present study, simple and sensitive spectrophotometric method was developed for the estimation and validation of Bicalutamide in bulk and Pharmaceutical dosage form by UV spectroscopy as per ICH guidlines. The maximum absorbance (λmax) of Bicalutamide in methanol was found to be 272 nm against methanol as a blank. The Bicalutamide obeys the Beers law in the concentration range 2.5 to 15 μg/ml with a correlation coefficient of 0.999. The proposed method was applied for the estimation of Bicalutamide in pharmaceutical dosage form and % purity was found to be 99.96 to 100.06 that indicate the good agreement with the label claim. The accuracy of the proposed method was determined by recovery study at three different levels (50%, 100%, and 150%). The % recovery was found to be 99.6 to 100.2%. The precision study was carried out by intraday and interday. The % RSD was found to be &lt; 2 which indicates that the method is precise. The proposed method was a fast technique for the routine analysis of Bicalutamide in bulk and pharmaceutical dosage form.</p> 2020-09-30T00:00:00+00:00 Copyright (c) 2021 V. Hariharasudhan, P. Divakar, A. Maheswaran, D. Saravanan Validation of high performance liquid chromatography mass spectrometric method in negative ion mode for the estimation of Amlopdipine in human plasma using Amlopdipine D3 as internal standard 2020-09-14T11:03:02+00:00 P. Sathya Sowmya M. Swarna Sagar Shaik Salima E. Chandu Priya <p>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. Recent development in analytical methods has been resulted from the advancement of analytical instruments. The improvement of the analytical method development and analytical instruments have reduced the time of analysis, increased precision and accuracy and reduced costs of analysis. As a consequence, most of pharmaceutical organizations are investing huge amount of money for the establishment of advanced analytical laboratories. Analytical techniques are developed and validated for active pharmaceutical ingredients (API), excipients, drug products, degradation products and related substances, residual solvents, etc. As a result, it has become an integral part of the requirements of the regulatory organization. Analytical method development finally results in official test methods. These methods are used in quality control laboratories to ensure the identity, purity, safety, efficacy and performance of drug products. Regulatory authorities are placing greater emphasis on analytical methods in manufacturing. Drug approval by regulatory authorities requires the applicant to prove control of the entire process of drug development by using validated analytical methods.</p> 2020-09-14T09:31:54+00:00 Copyright (c) 2020 M. Swarna Sagar, P. Sathya Sowmya Validation of high performance liquid chromatography mass spectrometric method in positive ion mode for the estimation of Clopidogrel in human plasma using Clopidogrel D4 as internal standard 2020-09-14T11:12:34+00:00 P. Sathya Sowmya E. Chandu Priya Shaik Salima M. Swarna Sagar <p>The present project work was to develop a robust, rapid, simple and sensitive liquid chromatography mass spectrometry (LC-MS/MS) assay method for the quantification of clopidogrel in human plasma. A high performance liquid chromatography mass spectrometric method for the estimation of clopidogrel, in human plasma in positive ion mode was developed and validated using clopidogrel d4 as internal standard (is). Sample preparation was accomplished by solid phase extraction method. The eluted samples were chromatographed on kromasil 100 5c18, 100 x 4.6 mm, 5 µm (make: akzo nobel) using a mobile phase consisting of hplc grade acetonitrile: milli q/hplc grade water (90:10, v/v) the method was validated over a concentration range of 0.031 ng/ml to 15.077 ng/ml for clopidogrel. This validation report provides the results of analyte selectivity, matrix selectivity, matrix effect, sensitivity determinations, calibration standards and quality control samples data, precision and accuracy data, the results of recovery, various stabilities, run size evaluation and dilution integrity along with all pertinent documentation.</p> 2020-09-14T00:00:00+00:00 Copyright (c) 2020 P. Sathya Sowmya, E. Chandu Priya, Shaik Salima, M. Swarna Sagar Validation of high performance liquid chromatography mass spectrometric method in negative ion mode for the estimation of Monomethyl fumarate in human plasma using Monomethyi fumarate D3 as internal standard 2020-09-14T11:12:17+00:00 P. Sathya Sowmya Shaik Salima M. Swarna Sagar E. Chandu Priya <p>The present project work was to develop a robust, rapid, simple and sensitive liquid chromatography mass spectrometry (LC-MS/MS) assay method for the quantification of monomethyl fumarate in human plasma. An analytical method employing LC-MS/MS using human plasma was developed and fully validated for the estimation of Monomethyl fumarate in human plasma by using monomethyl fumarateD3 as internal standarad. The solid phase extraction technique (SPE) was used for the extraction of the drug and Internal standard (IS). The chromatographic separation was achieved on a Zodiac C18 column by using a 70:30 (v/v) mixture of acetonitrile and 0.1% formic acid as the mobile phase at a flow rate of 0.5 mL/min. Totally five precision and accuracy batches were performed during the entire validation and intra-day and inter-day precision and accuracy were proved. KEYWORDS: Monomethyl fumarate, Human plasma, LC–MS/MS, Pharmacokinetics, Quantification.</p> 2020-09-14T00:00:00+00:00 Copyright (c) 2020 P. Sathya Sowmya, Shaik Salima, E. Chandu Priya, M. Swarna Sagar Analytical method development and validation of Rasagiline mesylate in bulk and doasage form by UV spectroscopy 2020-09-06T18:53:21+00:00 T. Vimalakkannan T. Praveen Kumar <p>A simple, rapid and precise uv spectroscopy method was developed for quantitative determination of rasagiline mesylate in bulk and dosage forms. This method was based on the beer’s lamberts law and The linearity was found to be in the concentration range of 50-300µg/ml and maximum absorbance was measured at 263nm 0.1m sulphuric acid as a solvent. The method was validated statistically and by recovery studies. Recovery was found to be in the range of 98 -102% and the %R.S.D was found to be less than 2%. The proposed method was economical and sensitive for the estimation of Rasagiline Mesylate (RM) in bulk and tablet dosage.</p> 2020-06-30T00:00:00+00:00 Copyright (c) 2020