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Validated Analytical Method for Multicomponent Analysis of Famotidine and Ofloxacin in Bulk drug and Tablet Formulation by using UV-Visible Spectrophotometer and RP-HPLC 验证了用紫外可见分光光度法和反相高效液相色谱法分析原料药和片剂中法莫替丁和氧氟沙星含量的方法
Asian Journal of Pharmaceutical Analysis Pub Date : 2023-09-07 DOI: 10.52711/2231-5675.2023.00026
Pooja Kaushal, Shiv Kumar Kushawaha, Manish Majumder, Mahendra Singh Ashawat
{"title":"Validated Analytical Method for Multicomponent Analysis of Famotidine and Ofloxacin in Bulk drug and Tablet Formulation by using UV-Visible Spectrophotometer and RP-HPLC","authors":"Pooja Kaushal, Shiv Kumar Kushawaha, Manish Majumder, Mahendra Singh Ashawat","doi":"10.52711/2231-5675.2023.00026","DOIUrl":"https://doi.org/10.52711/2231-5675.2023.00026","url":null,"abstract":"A simple, sensitive, accurate, precise, and reproducible UV- spectrophotometric method and RP-HPLC methods were developed and validated for the estimation of Famotidine and Ofloxacin in bulk drug and pharmaceutical formulation. The Linearity regression was detected and shows a good linear relationship; in the concentration range of 10-50µg/mL (R2 >0.9908) for famotidine and 10-50µg/mL (r2>0.9913) for ofloxacin. The UV – spectrophotometric estimation was carried out by the first-order derivative spectrophotometric method and absorbance were recorded at 273 and 280nm. Beers range were found to be 5-50µg/mL, respectively for both drugs while, correlation coefficient r2 > 0.9988 and 0.9941 for famotidine and ofloxacin. The isoabsorptive point was found to be 274nm in HPLC optimized mobile phase composition, potassium dihydrogen orthophosphate: methanol (60:40). Chromatographic condition consisted of mobile phase potassium dihydrogen orthophosphate buffer pH 2.3, methanol (60:40v/v), run time 30 min, C-18 column (ODS Hypersil) and flow rate 0.8mL/minute. The retention time for famotidine and ofloxacin were found to be 2.44 min, 7.99 min. respectively, and detection at λmax 274nm for both drugs (overlain spectra). The UV methods and RP-HPLC showed good reproducibility and recovery with the percent relative standard deviation (RSD) less than 5%. As per ICH guidelines, the developed method was validated for linearity, accuracy, precision, Sandell's sensitivity, and repeatability proving its utility in the estimation of famotidine and ofloxacin in house tablet formulation.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135097617","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Development and Validation of UV Spectroscopy Method for the Determination of Posaconazole in Bulk and Formulation 紫外光谱法测定泊沙康唑原料药和制剂含量的建立与验证
Asian Journal of Pharmaceutical Analysis Pub Date : 2023-09-07 DOI: 10.52711/2231-5675.2023.00027
Shivprasad Patil, Ajay Kshirsagar, Kartik Ade, Akash Bharkade, Madhav Bharkade, Ashish Birkalwar, Mahesh Chandolkar
{"title":"Development and Validation of UV Spectroscopy Method for the Determination of Posaconazole in Bulk and Formulation","authors":"Shivprasad Patil, Ajay Kshirsagar, Kartik Ade, Akash Bharkade, Madhav Bharkade, Ashish Birkalwar, Mahesh Chandolkar","doi":"10.52711/2231-5675.2023.00027","DOIUrl":"https://doi.org/10.52711/2231-5675.2023.00027","url":null,"abstract":"The present study was undertaken to develop a spectrophotometric method for the determination of Posaconazole (PCZ) in pharmaceutical dosage forms. This paper describes a simple, rapid, accurate, and precise UV-spectrophotometric method for the assay of PCZin bulk and marketed dosage forms. The validation of the developed method was carried out according to ICH guidelines concerning linearity, precision, accuracy, specificity, the limit of detection, and the limit of quantification. The diluent is aqueous methanol. Calibration curves were obtained in the concentration range of 04-20µg/ml for PCZ and with good correlation coefficients (R2=0.9981). The precisions of the new method for the drug were less than the maximum allowable limit (%RSD < 2.0) specified by the ICH. Therefore, the method was found to be accurate, reproducible, and sensitive for the analysis of PCZ in pharmaceutical dosage forms.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135097614","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Development and Validation of UV Spectroscopic Method for Simultaneous Estimation of Remogliflozin Etabonate and Vildagliptin in bulk and Pharmaceutical Dosage Form 紫外光谱法同时测定原料药和制剂中瑞格列净和维格列汀含量的建立与验证
Asian Journal of Pharmaceutical Analysis Pub Date : 2023-06-03 DOI: 10.52711/2231-5675.2023.00012
Vashi Dhara, Chaudhari Hetvi
{"title":"Development and Validation of UV Spectroscopic Method for Simultaneous Estimation of Remogliflozin Etabonate and Vildagliptin in bulk and Pharmaceutical Dosage Form","authors":"Vashi Dhara, Chaudhari Hetvi","doi":"10.52711/2231-5675.2023.00012","DOIUrl":"https://doi.org/10.52711/2231-5675.2023.00012","url":null,"abstract":"A new, simple, precise, accurate, reproducible, and efficient UV spectroscopic method was developed and validated for simultaneous estimation of Remogliflozin Etabonate and Vildagliptin in pure and pharmaceutical dosage form. The 𝜆max of Remogliflozin Etabonate and Vildagliptin in Methanol were found to be 236nm and 215nm, respectively. Calibration curves of Remogliflozin Etabonate and Vildagliptin were found to be linear in the concentration ranges of 5-25µg/mL and 1-5µg/mL with their correlation coefficient values (R2) 0.9993 and 0.9998, respectively. LOD and LOQ were found to be 0.0246µg/mL and 0.0745µg/mL for Remogliflozin Etabonate and 0.0278µg/mL and 0.0842µg/mL for Vildagliptin, respectively. In the precision study, the % RSD value was found within limits (RSD < 2%). The percentage recovery at various concentration levels varied from 99.25 to 101.06% for Remogliflozin Etabonate and 99.58 to 100.41% for Vildagliptin, respectively. The proposed method can be applied successfully for the simultaneous estimation of Remogliflozin Etabonate and Vildagliptin in pure and pharmaceutical dosage form. In this method simultaneous equation method was applied to find assay of both drugs in pharmaceutical dosage form.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73026945","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Recent Applications of UV-Visible Derivative Spectroscopic Method 紫外可见导数光谱法的最新应用
Asian Journal of Pharmaceutical Analysis Pub Date : 2023-06-03 DOI: 10.52711/2231-5675.2023.00019
Amit J. Vyas, Harshal M. Vadile, Ajay I. Patel, Ashok B. Patel, Ashvin V. Dudhrejiya, Sunny R. Shah, Urvi J. Chotaliya, Devang B. Sheth
{"title":"Recent Applications of UV-Visible Derivative Spectroscopic Method","authors":"Amit J. Vyas, Harshal M. Vadile, Ajay I. Patel, Ashok B. Patel, Ashvin V. Dudhrejiya, Sunny R. Shah, Urvi J. Chotaliya, Devang B. Sheth","doi":"10.52711/2231-5675.2023.00019","DOIUrl":"https://doi.org/10.52711/2231-5675.2023.00019","url":null,"abstract":"Derivative spectrophotometry is an analytical technique of great utility for extracting both qualitative and quantitative information from spectra composed of unresolved bands, and for eliminating the effect of baseline shifts and baseline tilts. Derivative spectrophotometry in the field of pharmaceutical analysis during the period 2018 – 2022 are reviewed. This paper draws attention to the fact that derivative treatment continues to be a promising tool for Multi-component Determination, Kinetic Studies, Pharmaceutical, clinical Analysis, Environmental fields of analysis or Food Analysis as it provides selective, validated, simple and cost-effective analytical method.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80511986","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Method Development using a UV Visible Spectrophotometer for the Simultaneous Estimation of Rabeprazole, Aceclofenac and Paracetamol in Marketed Formulation 方法采用紫外可见分光光度法同时测定市售制剂中雷贝拉唑、乙酰氯芬酸和扑热息痛的含量
Asian Journal of Pharmaceutical Analysis Pub Date : 2023-06-03 DOI: 10.52711/2231-5675.2023.00013
Wajid Ahmad, Rihan Jawed
{"title":"Method Development using a UV Visible Spectrophotometer for the Simultaneous Estimation of Rabeprazole, Aceclofenac and Paracetamol in Marketed Formulation","authors":"Wajid Ahmad, Rihan Jawed","doi":"10.52711/2231-5675.2023.00013","DOIUrl":"https://doi.org/10.52711/2231-5675.2023.00013","url":null,"abstract":"Rheumatoid arthritis, or RA, is an autoimmune and inflammatory disease, which means that your immune system attacks healthy cells in your body by mistake, causing inflammation (painful swelling) in the affected parts of the body. RA mainly attacks the joints, usually many joints at once. A complexation, derivatization, extraction, evaporation and sensitive-free direct a new, simple, precise, accurate, reproducible, and efficient UV spectrophotometric method is developed and validated for the simultaneous estimation of ternary mixture of rabeprazole, (MET) aceclofenac (SXG) and paracetamol (DGF) in both their bulk form and combined in tablet dosage form recently approved by FDA in 2019 to be used for treatment of Type 2 diabetes mellitus by simultaneous equation method. The solutions of standard and sample were prepared in methanol: water (80:20 v/v). The 𝜆max for MET, SXG, and DGF were 232.0, 212.0 and 272.0nm, respectively. Calibration curves are linear in the concentration ranges 10-50𝜇g/ml for MET, 1-5𝜇g/ml for SXG and 5-25𝜇g/ml for DGF, respectively. Results of analysis of simultaneous equation method were analyzed and validated for various parameters according to ICH guidelines.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87215321","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Review of HPLC Method Development and Validation as per ICH Guidelines 根据ICH指南的HPLC方法开发和验证综述
Asian Journal of Pharmaceutical Analysis Pub Date : 2023-06-03 DOI: 10.52711/2231-5675.2023.00024
Akash D. Rajmane, Komal P. Shinde
{"title":"A Review of HPLC Method Development and Validation as per ICH Guidelines","authors":"Akash D. Rajmane, Komal P. Shinde","doi":"10.52711/2231-5675.2023.00024","DOIUrl":"https://doi.org/10.52711/2231-5675.2023.00024","url":null,"abstract":"Method development and validation are continuous processes that progress in parallel with the evolution of drug products. Changes encountered during drug development may require modifications to existing analytical methods. These modifications to the methods, in turn, may require additional validation. The advent of new techniques and improved instrumentation in the field of analysis may give way to more sensitive, precise, and accurate methods if the existing methods are erratic or unreliable; time-consuming, or too expensive. Thus, continuous new analytical method development and validation activities are essential for the growing drug development programs.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82601744","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Review UV Method Development and Validation 紫外检测方法发展与验证综述
Asian Journal of Pharmaceutical Analysis Pub Date : 2023-06-03 DOI: 10.52711/2231-5675.2023.00021
Komal P. Shinde, Akash D. Rajmane
{"title":"A Review UV Method Development and Validation","authors":"Komal P. Shinde, Akash D. Rajmane","doi":"10.52711/2231-5675.2023.00021","DOIUrl":"https://doi.org/10.52711/2231-5675.2023.00021","url":null,"abstract":"Ultraviolet spectroscopy is one important and advanced analytical instrument in the Pharmaceutical industry and used for the last 35 years. The method of analysis is based on measuring the absorption of monochromatic light by colorless compounds in the near-ultraviolet path of the spectrum (200-400nm). The pharmaceutical analysis comprises the procedures necessary to determine such compounds' “identity, strength, quality, and purity”. It also includes the analysis of raw materials and intermediates during the manufacturing process of drugs. The fundamental principle of operation of a spectrophotometer covering the UV region consists that light of a definite interval of wavelength passes through a cell with solvent and falls onto the photoelectric cell that transforms the radiant energy into electrical energy measured by a galvanometer. Ultraviolet-visible spectroscopy is used to obtain the absorbance spectra of a compound in solution or as a solid.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89585250","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Review on Stability Indicating Assay Method or Forced Degradation Study: Strategy and Regulatory Consideration 稳定性指示测定方法或强制降解研究综述:策略和监管考虑
Asian Journal of Pharmaceutical Analysis Pub Date : 2023-06-03 DOI: 10.52711/2231-5675.2023.00022
Amit J. Vyas, Chirag D. Jadav, Ajay I. Patel, Ashok B. Patel, Sunny R. Shah, D. Sheth, S. Dholakia
{"title":"Review on Stability Indicating Assay Method or Forced Degradation Study: Strategy and Regulatory Consideration","authors":"Amit J. Vyas, Chirag D. Jadav, Ajay I. Patel, Ashok B. Patel, Sunny R. Shah, D. Sheth, S. Dholakia","doi":"10.52711/2231-5675.2023.00022","DOIUrl":"https://doi.org/10.52711/2231-5675.2023.00022","url":null,"abstract":"Stability-indicating methods are crucial analytical techniques that aim to evaluate the stability of a drug substance or product over time. They are designed to detect any alterations in the drug's chemical, physical, or biological characteristics that may occur during storage, transportation, and usage. These modifications can significantly impact the drug's safety and effectiveness, making stability testing an integral part of pharmaceutical quality control. The stability-indicating methods are used to identify the degradation products of a drug, quantify the rate of degradation, and determine the factors that may contribute to degradation. These conditions can include exposure to light, heat, humidity, and various chemical and physical stressors. The methods can be chromatographic or spectrophotometric and undergo validation to ensure their reliability, accuracy, and specificity for the specific drug. The acceptable level of degradation in forced degradation studies should not exceed 5-30% of the total active ingredient present in the drug substance or product. This helps to ensure that the results obtained are trustworthy and can be used to make informed decisions about the stability of the drug.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90192461","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Bio-Chemical Analysis of Pachai Karpoora Mathirai Pachai Karpoora Mathirai的生化分析
Asian Journal of Pharmaceutical Analysis Pub Date : 2023-06-03 DOI: 10.52711/2231-5675.2023.00023
R. Saraswathi, A. Elavarasi
{"title":"Bio-Chemical Analysis of Pachai Karpoora Mathirai","authors":"R. Saraswathi, A. Elavarasi","doi":"10.52711/2231-5675.2023.00023","DOIUrl":"https://doi.org/10.52711/2231-5675.2023.00023","url":null,"abstract":"Siddha system of medicine is ancient and traditional medicine based on pancha bootha theory and taste based medicine. Human body also based on pancha bootha theory, any imbalance in pancha bootham in human body alter the three vital humors (Vatham, Pitham and Kabam) causes disesease in human.20 So human disease can be treated with panchabootha theory based siddha drugs. Pacchai Karpoora mathirai is siddha medicine used for treating all type of fever (Suram) Especially kabasuram. Kabasuram is a siddha term more are less co related to Bronchitis in modern aspect of medicine in pediatric age group. Author decided to use a Pacchai karpoora mathirai for treating the kabasuram (Bronchitis) based on ingridients in the drug.13,14,15,16,17. The bio-chemical analysis of Pacchai Karpoora Mathirai was done in Biochemistry lab, National Institute of siddha, Chennai-47. Preliminary qualitative phytochemical screening was done by Kolkate (1) method. The bio-chemical analysis shows the presence of Carbonate, Aluminium, Zinc, Magnesium.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78757454","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A New Zero Cross Technique for Simultaneous Estimation of Rosuvastatin Calcium and Fenofibrate in Tablets by UV Derivative Spectroscopic Method 零交叉紫外导数光谱法同时测定瑞舒伐他汀钙和非诺贝特片剂的含量
Asian Journal of Pharmaceutical Analysis Pub Date : 2023-06-03 DOI: 10.52711/2231-5675.2023.00017
M. Pranati, N. Rani, B. Pravallika
{"title":"A New Zero Cross Technique for Simultaneous Estimation of Rosuvastatin Calcium and Fenofibrate in Tablets by UV Derivative Spectroscopic Method","authors":"M. Pranati, N. Rani, B. Pravallika","doi":"10.52711/2231-5675.2023.00017","DOIUrl":"https://doi.org/10.52711/2231-5675.2023.00017","url":null,"abstract":"A Simple and reliable Zero cross technique for simultaneous estimation of Rosuvastatin Calcium and Fenofibrate in tablets by using UV derivative method was developed. The quantitative determination of the drugs was carried out using the Zero cross values measured at 235nm and 273nm for Rosuvastatin Calcium and Fenofibrate respectively. The Calibration curves constructed at these wavelengths for the determination of the linearity in the concentration range of 5-25µg/mlfor both the selected drugs. The low relative standard deviation values indicate good precision and higher recovery values indicate accuracy of the proposed method. The developed zero cross technique was found to be simple, accurate, precise, specific, sensitive and reproducible which can be directly and easily applied tomarketed formulations.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89668518","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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