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Tag Archives: Method validation

Regulations and Management of Biological Products

B. Abhirami*, C.P. Sreekanth Reddy1, J. Praveen kumar2, E. Vijay Kumar3 *Krishna Teja Pharmacy College, Tirupati, A.P. 1Assistant Professor, Krishna Teja Pharmacy College, Tirupati, A.P 2Associate Professor, Krishna Teja Pharmacy College, Tirupati, A.P 3Assistant Professor, Srinivasa Institute of Pharmaceutical Sciences, Proddatur, A.P ABSTRACT The regulation of the biological and biotechnological products constitutes a significant challenge, since they are part of ... Read More »

Development and Validation of Stability Indicating RP-HPLC Method for the Determination of Irrinotecan in Bulk and It’s Pharmaceutical Dosage Form

Bonagiri Pavani*1, Dr. C. Hari kumar2, Y. Kesava3, Dr.B.Mohammed Ishaq4 1,2,3Vasavi Institute of Pharmaceutical Sciences, Kadapa, A.P, India 4Santhiram College of Pharmacy, Nandyala, A.P, India ABSTRACT A simple, sensitive, and specific reverse phase high performance liquid chromatographic method was developed and validated for the determination of Irinotecan in bulk and tablet dosage forms. The HPLC separation was carried out by ... Read More »

Novel validated reverse-phase chromatographic method for the stability-indicating studies of Tofacitinib dosage form

Birhanu Motbaynor* Haramaya University, College of Health and Medical Sciences, School of Pharmacy, Department of Pharmaceutical Chemistry, Harar, Ethiopia A  B  S  T  R A C T The objective of the current study was to develop and validate a rapid, precise, specific and stability-indicating reverse phase HPLC for the quantitative determination of TOFACITINIB in its dosage form. The determination is ... Read More »

Analytical Method Development and Validation of Apixaban and Dehydro Impurity by Using RP-HPLC

1Suryanarayana Gottapu*, Dr. Satyaveer Singh2 1Research Scholar, School of Pharmacy, OPJS University, Churu, Rajasthan 2Research Supervisor, School of Pharmacy, OPJS University, Churu, Rajasthan A B S T R A C T A simple and precise RP-HPLC method was developed for the determination of Apixaban impurities like Acid impurity and Amino acid impurity. The chromatographic separation was achieved on a Zorbax ... Read More »

A Novel Validated Stability Indacating Method for Simultaneous Estimation of Emtricitabine, Tenofovir and Efavirenz in Tablet Dosage Form by RP-HPLC

Kommana Balaram Kumar*, Yohanes Ayele, Birhanu Motbatnor aAssistant Professor, Department of Pharmaceutical analysis and Quality Assurance School of Pharmacy, Haramaya University, Ethiopia. bDepartment of clinical pharmacy, H.O.D, School of pharmacy, Haramaya University, Ethiopia cLecturer, Department of pharmaceutical analysis and quality assurance School of pharmacy, Haramaya University, Ethiopia A  B  S  T  R A C T The objective of the current study ... Read More »

Review on Analytical Method Validation Procedures

k. Surendra*, SK. Karishma, G. Obulesu, M. Naveena Rao’s College of Pharmacy, Chemudugunta, Venkatachalam, Nellore, Andhra Pradesh-524320 A B S T R A C T Pharmaceutical analysis plays a very prominent role in quality assurance as well as quality control of bulk drugs and pharmaceutical formulations, of which analytical method development & validation is the basic activity. Analytical techniques are ... Read More »

Analytical Method Development and Validation for the Estimation of Lacidipine in Bulk and Dosage Form by RP-HPLC

Dandu Girija1*, Akkimi Padma1, A. Thirupathireddy2, B. Venkateswara reddy3 1Assistant professor, Department of Pharmaceutical Analysis, Sankar Reddy Institute of Pharmaceutical sciences, Salakalveedu(v), Bestavaripeta(M), Prakasam(Dist) Andha pradesh       pin -523370. 2Associate Professor, Department of Pharmaceutics, Sankar Reddy Institute of Pharmaceutical sciences, Salakalveedu(v), Bestavaripeta(M), Prakasam(Dist) Andha pradesh  pin – 523370. 3Professor, Department of Pharmaceutics, Sankar Reddy Institute of Pharmaceutical sciences, Salakalveedu(v), Bestavaripeta (M), ... Read More »

Development and Validation of a RP-HPLC Method for the Determination of Acyclovir in Transdermal Patches

R. Venu Priya1 and Vinesh Kumar2 1Research Scholar, Sun Rise University, Alwar, Rajasthan, India. 2Department of Pharmacy, Sun Rise University, Alwar, Rajasthan, India. A B S T R A C T The present report describes a rapid and sensitive High Pressure Liquid Chromatography (HPLC) method with UV detection to quantify acyclovir in transdermal patches. After sample preparation with diluent separation ... Read More »

Genotoxic Impurity Profiling of Imatinib Mesylate

1M. Rajavardhan Reddy*, 2Dr. R. Suresh, 3Dr.K. Kannan 1Research Scholar, Annamalai University, Tamil Nadu, India 2Department of Pharmaceutical Chemistry, Annamalai University, Tamil Nadu, India 3Head of the Department, Pharmaceutical Sciences, Annamalai University, Tamil Nadu, India A B S T R A C T Genotoxic impurities (GTIs) in pharmaceuticals are of increasing concerns to both pharmaceutical industries and regulatory agencies due ... Read More »

Analytical Method Development and Validation of Chloro Impurity and Methyl Ester Impurity by using RP-HPLC

Suryanarayana Gottapu*1, Hirdayesh kumar Vatsa1, B. Anitha2 1Monad Univeristy, Hapur, Rajasthan, India 2SARC (Scientific and Applied Research Center), Hyderabad, Telangana, India A B S T R A C T A simple and precise RP-HPLC method was developed for the determination of Apixaban impurities like Chloro impurity and Methyl ester impurity. The chromatographic separation was achieved on an Zorbax Bonus RP ... Read More »

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