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Tag Archives: ICH

Photo stability indicating UV visible spectrophotometric method for tezepelumab development and validation

Ajay Kumar Ch*,Bharghava Bhushan Rao P1,Jhansi M2, Jyothi D3, Narasimha Rao K4, Murali krishna M5, Narsu kumari6 *23456A.M.Reddy Memorial College of Pharmacy, Narasaraopet, 522412, A.P, India 1V V Institute of Pharmaceutical Sciences, Gudlavalleru, A.P, India A  B  S  T  R A C T Spectroscopy is the study of how electromagnetic radiation interacts with matter. Electromagnetic radiation is frequently released as ... Read More »

RP-HPLC Method Development and Validation for the Estimation of Olanzapine in bulk drug and tablet dosage form

Gobalakrishnan P*1, Munisekhar V, Hemanth Kumar V 1Department of Pharmaceutical Analysis, Vagdevi College of Pharmacy and Research Centre, Nellore, Andhra Pradesh, India. A  B  S  T  R A C T The methods developed for the determination of Olanzapine are simple, selective and offer the advantages of high sensitivity without the need for extraction.. A new method was developed for Stability ... Read More »

Prospective Study of Good Practice for Management of Comments / Deficiencies in CTD/eCTD

B. Ranganayakulu*, B.Nagalakshmi1, Dr. S. Mohammed Yusuf2, Dr.A.Srikanth3, N. Ravi Kumar4 *,2Associate Professor, Srinivasa Institute of Pharmaceutical Sciences, Proddatur, A.P., India 1,4Srinivasa Institute of Pharmaceutical Sciences, Proddatur, A.P., India 3Assistant Professor, Vasavi Institute of Pharmaceutical Sciences, Kadapa, A.P., India Int. J. Med. Pharm. Res.,  2020, 8(1): 5-8 A B S T R A C T eCTD or electronic common technical document ... Read More »

Observations on Guidelines for Post Marketing Surveillance for Pharmaceuticals

A. Kusumanjali*, J. Praveen Kumar1, E. Vijay Kumar2, Dr. P. Jaya Chandra Reddy3, Dr. S. Mohammed Yusuf4 *Krishna Teja Pharmacy College, Tirupati, A.P., India. 1Associate Professor, Krishna Teja Pharmacy College, Tirupati, A.P., India. 2Assistant Professor, Srinivasa Institute of Pharmaceutical Sciences, Proddatur, A.P., India. 3Principal, Krishna Teja Pharmacy College, Tirupati, A.P., India. 4Associate Professor, Srinivasa Institute of Pharmaceutical Sciences, Proddatur, A.P., India. ... Read More »

Analytical Method Development and Validation For in Vinblastine and Vincristine Combine Dosage Forms by RP–HPLC Method

K.Nithiyananthan1*, K.V.S.Prasadarao2 1Research Scholar, Acharya Nagarjuna University, Guntur, Andhra Pradesh 522510. 2Principal, Rahul Institute of Pharmaceutical Science And Research, Chirala, Andhra Pradesh 523157. A B S T R A C T The chromatographic conditions were successfully developed for the separation of Vinblastine and Vincristine by using XterraC185µm (4.6*250mm) column, flow rate was1ml/min, mobile phase ratio was Phosphate buffer (0.05M) pH4.6: ... Read More »

Development and Validation of a New Method for the Simultaneous Estimation of Metformin and Linagliptin in Bulk and Dosage form by using UV–Spectrophotometry

M. Mallikarjuna*, C. Guru Sudhakar, K. Siva Shankar, SK. Abid, P. Rameeja Ratnam Institute of Pharmacy, Pidathapolur, Nellore, AP, India ABSTRACT A Simple, Determined, and precise method to develop a new quantitative simultaneous identification of metformin hydrochloride and Linagliptin in combined pharmaceutical dosage forms. This method was based on the based on the UV spectrophotometric method for the simultaneous estimation of ... Read More »

Development of a new UV/Visible Spectophotometric and HPLC methods for simultaneous estimation of Metformin and Sitagliptin

Md. Salmasultana1, Asish Bhaumik*2, Hiroshima Kumari3, P. Lavanya4, A. Uma5, T. Haritha6 1,3,4Department of Pharmaceutical Analysis, Teja College of Pharmacy, Kodad, Nalgonda-508206, Telangana, India. 2,5,6Department of Pharmaceutical Chemistry, Teja College of Pharmacy, Kodad, Nalgonda-508206, Telangana, India. A B S T R A C T The main aim and objective of the present research work was to develop a new UV/VISIBLE ... Read More »

A COMPARISION OF ANALYTICAL METHOD VALIDATION PROCEDURES

About author: Chinmaya Keshari Sahoo* Research Scholar,Dept. of Pharmaceutics, OUCT, Osmania University,A.P, India *e-mail: [email protected] INTRODUCTION : Analytical method validation is a regulatory requirement that refers to the evaluation and proving that the selected analytical method shall ensure reproducible and reliable results adequate for the intended purpose.The process of analytical method validation should demonstrate that the method is fit for ... Read More »

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