STABILITY INDICATING RP-HPLC METHOD FOR THE ESTIMATION OF QUETIAPINE FUMARATE IN BULK AS WELL AS IN PHARMACEUTICAL DOSAGE FORM

This study was designed to develop and validate a simple, sensitive, precise, and specific stability indicating reverse phase high-performance liquid chromatographic (HPLC) method for estimation of Quetiapine Fumarate in bulk and its tablet dosage form. The HPLC separation was carried out by reverse phase chromatography on Thermo column Symmetry C18 (4.6 x 150mm, 5 mm) with a mobile phase composed Sodium dihydrogen phosphate and the pH was adjusted to 4.0 by Orthophosporic Acid & Methanol in the ratio of 35:65 v/v in isocratic mode at a flow rate of 1.0 ml/min. The run time was maintained for 6mins. The detection was monitored at 290 nm. The calibration curve for Quetiapine Fumarate was linear from 20 to60 µg/ml. The inter-day and intra-day precision was found to be within the limits. The proposed method was adequate sensitivity, reproducibility, and specificity for the determination of Quetiapine Fumarate in bulk and its tablet dosage forms. The limit of detection [LOD] and limit of quantification [LOQ] for Quetiapine Fumarate were found to be 0.01 µg/ml and 0.03 µg /ml respectively. The Accuracy recoveries were 100.0-100.4% and reproducibility was found to be satisfactory. The bulk active pharmaceutical ingredient was subjected to  thermal,  photolytic,  hydrolytic  (acidic  and  basic)  and  oxidative  stress  conditions  and  stressed  samples  were analyzed by the proposed method. The method was validated in terms of linearity, precision, accuracy, specificity and robustness. All the validation was done as per ICH guidelines. The proposed method was simple, fast, accurate, and precise for the quantification of Quetiapine Fumarate in the dosage form, bulk drugs as well as for routine analysis in quality control. Key-Words: Quetiapine Fumarate, RP-HPLC, ICH, Stability Indicating Studies, LOD, LOQ

Simultaneous Estimation of Amlodipine Besylate and Nebivolol Hydrochloride in Pharmaceutical Tablets Formulation by RP-HPLC Using PDA Detector: Simultaneous estimation of amlodipine besylate and nebivolol hydrochloride

The present work was undertaken with the aim to develop and validate a rapid and consistent RP-HPLC method in which the peaks will be appear with short period of time as per ICH Guidelines.The separation was achieved on a stainless steel analytical column, Eclipse XDB plus C18 column (4.6 X 150 mm; 5 μm) in an isocratic mode. The mobile phase was composed acetonitrile and 0.01 M ammonium acetate (pH adjusted to 4.5 using glacial acetic acid), which were mixed in the ratio of 50: 50. The flow rate was monitored at 1.0 mL/min. The wavelength selected for detection was 265 nm. The retention time found for amlodipine besylate and nebivolol hydrochloride was 2.967 and 3.510 min, respectively. The % recovery was 100.20- 100.86 for amlodipine and 100.20 - 100.78 for nebivolol. The linearity was established in the range of 5-25 μg/mL for amlodipine and 10-50 μg/mL for nebivolol. The slope, intercept, and correlation coefficient were found to be 314.2x, +162.4, and 0.999 for amlodipine besylate and 248x, -305.7, and 0.9998 for nebivolol hydrochloride, respectively. The limits of detection for amlodipine besylate and nebivolol hydrochloride obtained by the proposed method was 0.07 and 0.20 μg/ml and the limits of quantification for amlodipine besylate and nebivolol hydrochloride obtained by the proposed method was 0.23 and 0.61 μg/mL, respectively. The method was found to be suitable for the quality control test of amlodipine besylate and nebivolol hydrochloride simultaneously in a bulk drugs as well as in a formulations

Rotatory vibration of sphere of higher order viscoelastic solid

An attempt is made to investigate the rotatory vibration of a sphere of higher order viscoelastic solid considering higher order strain rate and stress rate. The general frequency equation is obtained for this type of vibration of a sphere. As a special case of this analysis, the frequency equations for the first order and the second order viscoelastic solids are derived. It is shown that the classical frequency equation for an isotropic elastic solid follows from this analysis

New Validated Stability-Indicating Rp-HPLC Method for Simultaneous Estimation of Atorvastatin and Ezetimibe in Human Plasma by Using PDA Detector

Purpose: This paper describes a simple, precise and accurate RP-HPLC method for simultaneous estimation of atorvastatin and ezetimibe in plasma. Methods: The chromatographic separation of the drugs were performed on an X-Terra C8 (4.6 x 150 mm, 3.5 mm), with phosphate buffer [pH 3.5 with Ortho Phosphoric Acid] – acetonitrile 40:60 (v/v) as mobile phase. The detection was performed at 235 nm. The flow rate was maintained at 1.2 mL/min. The run time was 8.0 min. Results: The accuracy and reliability of the method was assessed by evaluation of linearity (5-25 µg/mL for both atorvastatin calcium and ezetimibe), precision (intra-day RSD 0.57 % and inter-day RSD 0.02 % for atorvastatin calcium and intra-day RSD 0.56 % and inter-day RSD 0.1 % for ezetimibe), accuracy (100.08- 100.84 % for atorvastatin calcium and 100.56- 101.00 % for ezetimibe), and specificity, in accordance with ICH guidelines. The LLOQ obtained by the proposed method were 1.294 and 1.384 µg/mL for atorvastatin and ezetimibe respectively. Conclusion: Overall the proposed method was found to be suitable and accurate for the quantitative determination in plasma. The method was effectively separated the drug from plasma

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT & VALIDATION FOR SIMULTANEOUS DETERMINATION OF DUTASTERIDE AND TAMSULOSIN IN BULK AS WELL AS IN PHARMACEUTICAL DOSAGE FORM BY USING PDA DETECTOR

ABSTRACT Objective: The present work was undertaken with the aim to develop and validate a rapid and consistent stability indicating RP-HPLC in which the peaks will be appear with short period of time as per ICH Guidelines. The proposed method was simple, fast, accurate and precise method for the Quantification of drug in the dosage form, bulk drug as well as for routine analysis in Quality control. Method: Reversed-phase high-performance liquid chromatography (RP-HPLC) methods was developed and validated for simultaneous estimation of Tamsulosin hydrochloride and Dutasteride in bulk drug and in combined dosage forms. RP-HPLC separation was achieved on a Symmetry C18 (4.6 x 150mm, 5mm, Make: XTerra) under an Isocratic Mode. The mobile phase was composed of Phosphate Buffer (20%) whose pH was adjusted to 2.5 by using Orthophosporic Acid & Acetonitrile (80%) [HPLC Grade]. The flow rate was monitored at 0.8 ml per min. The wavelength was selected for the detection was 274 nm. Result: The run time was 7min. The retention time found for the drugs Dutasteride & Tamsulosin were 2.003 min. & 5.067 min. respectively. The linearity was established in the range of 25 to 125µg/ml. The proposed method was adequate sensitive, reproducible, and specific for the determination of Dutasteride and Tamsulosin hydrochloride in bulk as well as in Pharmaceutical dosage form. The validation of method was carried out utilizing ICH-guidelines. Conclusion: The described RP-HPLC method was successfully employed for the analysis of pharmaceutical formulations containing combined dosage form. The drug was exposed to Thermal, Hydrolytic and Oxidative stress conditions and the stressed samples were analyzed by the proposed method. The peak homogeneity data for the drugs Dutasteride and Tamsulosin hydrochloride were obtained by using Photodiode Array Detector in the stressed sample chromatograms which demonstrated the specificity of the method for the estimation in the presence of degradants. Overall the proposed method was found to be suitable and Accurate for the Quantitative determination and stability study of the drug in Pharmaceutical dosage form. . The method was effectively separated the drug from its degradation product and it was employed as a stability- indicating one. The method was simple, precise, accurate and sensitive and applicable for the simultaneous determination of Dutasteride and Tamsulosin hydrochloride in bulk drug and in combined dosage forms. Keywords: Tamsulosin, Dutasteride, ICH Guideline, RP-HPLC, LOD, LOQ

Abstracts of 1st International Conference on Machine Intelligence and System Sciences

This book contains the abstracts of the papers presented at the International Conference on Machine Intelligence and System Sciences (MISS-2021) Organized by the Techno College of Engineering, Agartala, Tripura, India & Tongmyong University, Busan, South Korea, held on 1–2 November 2021. This conference was intended to enable researchers to build connections between different digital technologies based on Machine Intelligence, Image Processing, and the Internet of Things (IoT). Conference Title: 1st International Conference on Machine Intelligence and System SciencesConference Acronym: MISS-2021Conference Date: 1–2 November 2021Conference Location: Techno College of Engineering Agartala, Tripura(w), IndiaConference Organizer: Techno College of Engineering, Agartala, Tripura, India & Tongmyong University, Busan, South Korea