{"title":"A new simple RP-HPLC Method development, Validation and Forced degradation studies of Bilastine","authors":"Khushbu K. Patel, A. Patel, C. N. Patel","doi":"10.52711/2231-5675.2021.00031","DOIUrl":"https://doi.org/10.52711/2231-5675.2021.00031","url":null,"abstract":"A new simple, rapid, accurate and precise method for estimation of Bilastine in pharmaceutical dosage form by reverse phase liquid chromatography. The developed method employed mobile phase was Acetonitrile and Ammonium acetate pH 5.0 adjusted with glacial acetic acid with 85:15% v/v and flow rate 1.0ml/min. Method was developed using column C18 Water (150 × 4.6mm, 5µm) and detection wavelength was 215nm. The retention time was found to be 2.519 min. the proposed method was successfully applied to the determination of Bilastine in dosage form. High linearity of developed method was confirmed over concentration range of 25- 150 µg/ml and co-relation co-efficient is 0.996. The percentage RSD for precision and accuracy of the method was found to be less than 2%. The recovery was in the range of 99 – 102% and limit of detection was found to be 0.45µg/ml and limit of quantification was found to be 1.20µg/ml. Bilastine was found to degrade under acid and oxidation conditions. There was no interference of excipient and degradation product in retention time so method was specific. Analytical parameter such as precision, accuracy, limit of detection, limit of quantification and robustness were determined according to international Conference on Harmonization (ICH) guidelines.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"1997 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90456670","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}
Shivani Sharma, Navdeep Singh, A. Ankalgi, Arti Rana, M. Ashawat
{"title":"A Precise Review on Applications and Basic Concept of Direct Analysis in Real Time Mass Spectrometry (DART-MS)","authors":"Shivani Sharma, Navdeep Singh, A. Ankalgi, Arti Rana, M. Ashawat","doi":"10.52711/2231-5675.2021.00042","DOIUrl":"https://doi.org/10.52711/2231-5675.2021.00042","url":null,"abstract":"Direct real time analysis (DART) is the most successful tool for the analysis of the compounds. This technique is useful for the identification, and classification of compounds. It is widely followed by the forensic chemistry, and also used for many purposes. Their main applications include inks, paints, drugs, bank dyes, explosives, beverages, and gunshot etc. The basic concepts of DART-MS were highlighted to understand the process. Also the basic fundamentals of DART-MS including special function were discussed. Various natural products were discovered by DART-MS includes plant tissue, insects, and microbe etc. The main focus of this review article is on the applications of direct real time analysis, which covers the varieties of uses in our pharmaceutical as well as chemical industries. This technique was helpful in the production of food material, and to identify the contaminants from animal sources in the part of veterinary drugs. Also, used in food processing in the form of additives, and adulterants. DART-MS has huge applications on analysis of seized drug like steroids supplements, psychoactive plants etc. Also, in inks, paint, and documents industry this technique has been widely used. So, this review covers the basic fundamentals of direct real time analysis DART-MS, and their applications.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"41 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78027084","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}
D YelekarP, Chaudhari S.B, D ChourasiaR, R TikariyaK, B. Payal
{"title":"To Estimate the Label claim of tablet in their combination by simultaneous estimation using UV-Visible Spectrophotometric method","authors":"D YelekarP, Chaudhari S.B, D ChourasiaR, R TikariyaK, B. Payal","doi":"10.52711/2231-5675.2021.00033","DOIUrl":"https://doi.org/10.52711/2231-5675.2021.00033","url":null,"abstract":"Objective: The main objective of the work was to check the label claim of tablet in combination by Simultaneous estimation by UV method. Method: Spectrophotometric method development and validation are plays important role in the development and manufacture of pharmaceuticals. This Spectrophotometric method was a simple and reproducible for the quantitative determination of Paracetamol and Caffeine in tablet formulation was developed and validated in the present work. The various parameters like specificity, linearity, precision, accuracy, robustness and ruggedness were studied according to ICH guidelines. The wavelength 273nm was selected for the estimation of Caffeine using distilled water as a solvent and the wavelength 243nm selected for the estimation of Paracetamol using distilled water as solvent the drug obeyed Beer’s-Lambert’s law over the concentration range 20-120µg/ml. Recovery study was performed to confirm the accuracy of the method. The method was successfully applied for routine analysis of this drug in formulation the method were validated as pr ICH guidelines. Conclusion: A simple UV spectrophotometric method was developed for the Simultaneous determination of Paracetamol and Caffeine in tablet formulation without any interference from the excipients. The present method succeeded in adopting a simple sample preparation that achieve satisfactory extraction recovery and facilitated its application in co formulated formulation.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"10 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84737595","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}
{"title":"Validated RP-HPLC method for the estimation of Amiloride and hydrochlorothiazide in combined tablet dosage form","authors":"R. Kumar, G. R. Babu, M. Sowjanya, M. Ramayyappa","doi":"10.52711/2231-5675.2021.00037","DOIUrl":"https://doi.org/10.52711/2231-5675.2021.00037","url":null,"abstract":"The aim of this work is to build up a fast, exact, precise and touchy reverse phase liquid chromatographic method for the synchronous assessment of amiloride and hydrochlorothiazide in tablet dose structure. The chromatographic strategy was normalized utilizing Hypersil ODS segment (250×4.6mm, 5μm molecule size) with UV discovery at 210nm and stream pace of 1ml/min. The portable stage includes phosphate buffer (pH acclimated to 2.5 with dilute Ortho Phosphoric acid) and acetonitrile in the proportion of 60:40 v/v. The linearity of proposed technique was examined in the scope of 5-30μg/ml (R²=0.999) for amiloride and 50-300μg/ml (R²=0.999) for Hydrochlorothiazide appropriately. The limit of detection (LOD) was discovered to be 0.10μg/ml and 0.40μg/ml for Amiloride and Hydrochlorothiazide appropriately. The limit of quantitation (LOQ) was discovered to be 0.30μg/ml and 1.20μg/ml for Amiloride and Hydrochlorothiazide separately. The retention times of Amiloride and Hydrochlorothiazide were found to be 3.258min and 2.383min separately. The technique was truly recommended and %RSD was found to be under 2 demonstrating serious level of exactness and accuracy. Subsequently proposed strategy can be effectively evaluated for the synchronous assessment of Amiloride and Hydrochlorothiazide in promoted formulations.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"7 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88858267","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}
A. Patel, Avadhi R. Bundheliya, A. Vyas, Nilesh Patel, Ajay I. Patel, Arvind N. Lumbhani
{"title":"A Review on Metal Impurities in Pharmaceuticals","authors":"A. Patel, Avadhi R. Bundheliya, A. Vyas, Nilesh Patel, Ajay I. Patel, Arvind N. Lumbhani","doi":"10.52711/2231-5675.2021.00038","DOIUrl":"https://doi.org/10.52711/2231-5675.2021.00038","url":null,"abstract":"Sources of metal impurities can from anywhere in drug product as raw material which may produce using metal catalyst, excipients, process materials, Water or any solvent used, manufacturing equipment, environment, packaging materials. So, it leads to metal impurity in high amount present in final drug product that is why it is important to check the impurity level in final drug product or as well as in process also that it should be present in low or acceptable amount. Any Drug product is not completely pure, some amount of metal impurities are always present in pharmaceutical product may cause various toxicity when it will be administered. Thus it is necessary to check impurity level is present at acceptable amount. The present review gives an account of updated information about metal impurities and reviews the regulatory aspects for such metal impurities in drug substance/drug product. In addition the aim of this article is to discuss the currently used different analytical techniques for detection of metals from drug product like spectrophotometry, X – Ray florescence spectrometry, AAS, INAA, ICP – AES, ICP – MS, MP – AES, Laser Ablation – ICP – MS etc which is used for quality control of metal impurities in pharmaceuticals.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91008161","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}
{"title":"UV Spectrophotometric Method Development and Validation of Dasatinib in Bulk and Formulation","authors":"Jyoti Mittha, Bhavana Habib","doi":"10.52711/2231-5675.2021.00036","DOIUrl":"https://doi.org/10.52711/2231-5675.2021.00036","url":null,"abstract":"UV-Spectrophotometric method has been developed and validated for quantitative estimation of dasatinib in bulk and pharmaceutical formulation. Dasatinib is soluble in acetonitrile, so it was used as solvent. Dasatinib was dissolved in acetonitrile and resulting solution was scanned in UV range (200-400nm). The λmax was found to be 315nm. Beers law is valid in concentration range of 5-25µg/ml. The developed method was validated for linearity, accuracy, precision, robustness; LOD and LOQ. Linearity was obtained in the range of 5-25µg/ml with correlation coefficient 0.9992. LOD and LOQ were found to be 0.908µg/ml and 2.752µg/ml respectively. The method showed good reproducibility and recovery so; proposed method can be applied for routine analysis of dasatinib in bulk and pharmaceutical formulation.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"18 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81436768","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}
{"title":"A Review article on Analytical Method Development for the combination of Azelnidipine and Telmisartan","authors":"Nirma Chavda, Suresh Kumar","doi":"10.52711/2231-5675.2021.00040","DOIUrl":"https://doi.org/10.52711/2231-5675.2021.00040","url":null,"abstract":"The literature survey explains that there is not any stability indicating method reportedly for combination of Azelnidipine and Telmisartan till date. Validation and development of stability indicating analytical methods is possible as per ICH Guidelines. There are several of Spectroscopic methods such as Ultraviolet Spectroscopy, Mass spectroscopy, infrared spectroscopy, Nuclear magnetic resonance spectroscopy and Chromatographic methods such as High performance liquid chromatography, Thin layer Chromatography, High Performance thin layer chromatography, Gas chromatography and Ultra performance liquid chromatography etc. used for stability indicating method development and validation.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"95 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80592660","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}
{"title":"Development and Validation of UV Spectroscopy Method for the Estimation of Dolutegravir in Bulk and Pharmaceutical Dosage Form","authors":"Vaishnavi Dulange, G. Gajeli","doi":"10.52711/2231-5675.2021.00032","DOIUrl":"https://doi.org/10.52711/2231-5675.2021.00032","url":null,"abstract":"UV spectroscopic method was developed for the estimation of Dolutegravir in bulk and Formulation.The UV spectrum of Dolutegravir in methanol and water mixture showed λ max at 254nm. Beer’s law is valid in the concentration range of 10-50µg/ml. This method was validated for linearity, accuracy, precision, LOD and LOQ. The method has demonstrated excellent linearity over the range of 10-50µg/ml with regression equation y = 0.030x + 0.008 and regression correlation coefficient r2= 0.998. Moreover, the method was found to be highly sensitive with LOD (2.056μg/ml) and LOQ (6.230μg/ml). Depending on results the given method can be successfully applied for assay of Dolutegravir in formulation.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"54 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84690240","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}
Ch. Prudhvi Raju, G. R. Babu, S. M., Ramayyappa M.
{"title":"Evaluation of Cancer Bio-markers through Hyphenated Analytical Techniques","authors":"Ch. Prudhvi Raju, G. R. Babu, S. M., Ramayyappa M.","doi":"10.52711/2231-5675.2021.00041","DOIUrl":"https://doi.org/10.52711/2231-5675.2021.00041","url":null,"abstract":"Background: The accurate and efficient diagnosis at the early stages of cancers is the key feature for effective treatment and productive research for finding out news to types of cancers. It is essentially true for cancers, where there is no effective cure, but only one treatment is available. But most people have a combination of treatments, such as surgery with chemotherapy or radiation therapy or immunotherapy or targeted therapy or hormone therapy.Cancers symptoms of abnormal periods or pelvic pain, changes in bathroom habits, bloating, breast changes, chronic coughing, chronic headache, difficulty swallowing, excessing bruising. Despite the fact of having great need, the current availability of diagnostic tests is unable to diagnose different forms of cancers. Aim: The aim of the review is to explore the application of GC-MS, LC-MS and UP-LC/Q-TOF MS for the evaluation of changes in the biochemical composition of blood serum, urine and saliva. The power of high differentiation method will promote the translation of hyphenated techniques from a laboratory to clinical useful tool. Determination of biochemical information derives from hyphenated techniques from blood, serum, saliva and urine that will yield accurate and selective detection of cancer disorders. They will also provide diagnostic and prognostic indicators and will also play a significant role in the development of personalized medicine. Conclusion: Hyphenated techniques will allow differentiating blood serum, saliva and urine samples of common cancer disorders from normal control patients with sensitivity and specificity.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88062712","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}
{"title":"Development and Validation of RP-HPLC Method for Analysis of Aclidinium Bromide and Formoterol Fumarate in Pharmaceuticals","authors":"Devadasu Ch., Bharani","doi":"10.52711/2231-5675.2021.00012","DOIUrl":"https://doi.org/10.52711/2231-5675.2021.00012","url":null,"abstract":"","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"159 1","pages":"63-69"},"PeriodicalIF":0.0,"publicationDate":"2021-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75683834","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}