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Author Archives: rameshdhani1665

Comparison Study for Drug Master file Procedure in USA & Canada with Regard to Regulatory Technicalities

Rajkiran Kolakota1 & N. Sireesha2* 1-2Department of Pharmaceutical Regulatory Affairs, Sri Sivani College of Pharmacy, NH-16, Chilakapalem Jn, Srikakulam-532402, AP. A  B  S  T  R A C T Drug Master File (DMF) is a document containing complete information on drugs and its related compounds i.e, Active Pharmaceutical Ingredient (API) or finished drug dosage form such as drug product’s chemistry, manufacture, ... Read More »

Process Involved for Registration of Generic Medicines and Format of Drug Dossiers in Australia

Rajkiran Kolakota1 & K.V.S.L. Kavya*2 1-2Department of Pharmaceutical Regulatory Affairs, Sri Sivani college of Pharmacy, NH-16, Chilakapalem Jn, Srikakulam-532402, AP. A  B  S  T  R A C T Therapeutic Goods Administration (TGA) guidelines will assist sponsors to prepare applications to register new prescription or other high risk medicines for human use in Australia, or to vary existing medicine registrations. The ... Read More »

Process Involved for Registration of Generic Medicines and Format of Drug Dossiers in Australia

Rajkiran Kolakota1 & K.V.S.L. Kavya*2 1-2Department of Pharmaceutical Regulatory Affairs, Sri Sivani college of Pharmacy, NH-16, Chilakapalem Jn, Srikakulam-532402, AP. A  B  S  T  R A C T Therapeutic Goods Administration (TGA) guidelines will assist sponsors to prepare applications to register new prescription or other high risk medicines for human use in Australia, or to vary existing medicine registrations. The ... Read More »

Analytical Method Development and Validation for Simultaneous Estimation of Salmeterol and Fluticasone Propionate in Bulk and Pharmaceutical Dosage form by RP-HPLC Method

Dr. Gampa Vijay Kumar1 K. Vishwapriya2 1Professor and Head, Dept. of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India. 2KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India. ABSTRACT High performance liquid chromatography is at present one of the most sophisticated tool of the analysis. The estimation of Salmeterol and Fluticasone propionate was done ... Read More »

RP-HPLC Method Development and Validation of Pregabalin and Nortriptyline in Bulk and Pharmaceutical Dosage Form

Dr. Gampa Vijay Kumar1, P. Sowjanya2, D. Tejaswini3 1Professor and Head, Dept. of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India. 2KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India. 3KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India. ABSTRACT High performance liquid chromatography is at present one of the most sophisticated ... Read More »

Simultaneous Estimation of Dosulepin HCl and Methylcobalamin by RP-HPLC

Dr. Gampa Vijay Kumar1, P. Sowjanya2,M. Swapna3 1Professor and Head, Dept. of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India. 2KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India. 3KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India. ABSTRACT High performance liquid chromatography is at present one of the most sophisticated tool ... Read More »

RP-HPLC Method Development and Validation for Simultaneous Estimation of Paroxetine and Clonazepam in Its Active Pharmaceutical Ingredient and Pharmaceutical Dosage Forms

Dr. Gampa Vijay Kumar1, Dr. T Rjesh2, T. Sai priya3 1Professor and Head, Dept. of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India. 2KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India. 3KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India ABSTRACT A new method was established for simultaneous estimation of Paroxetine ... Read More »

RP-HPLC Method Development and Validation for Simultaneous Estimation of Bempedoic Acid and Ezetimibe in Bulk and Pharmaceutical Dosage Form

Dr. Gampa Vijay Kumar1, Dr. D. Naresh2 S. Prasanna Bharathi3 1Professor and Head, Dept. of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India. 2KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India. 3KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India. ABSTRACT New method was established for simultaneous estimation of Bempedoic acid  ... Read More »

Evaluation of Antiepileptic Activity of Ethanolic Extract of Withnia Somnifera Leaves in Mice

Talloju Dheekshith1, Nagaraju K2, Gampa Vijay Kumar3 1,2,3KGR Institute of Technology and Management, Rampally, Vill, KesaraMdl, Medchal-501301, Telangana, India ABSTRACT The present study was designed to investigate the anti epileptic activity of Withania Somnifera. To evaluate the antiepileptic activity of ethanolic extract of Withania somnifera leaves (EEWS) against Maximal electroshock (MES) and Pentylenetetrazole (PTZ) induced seizures in mice. Acute toxicity ... Read More »

RP-HPLC Method Development and Validation for Simultaneous Estimation of Bempedoic Acid and Ezetimibe in Bulk and Pharmaceutical Dosage Form

Dr. Gampa Vijay Kumar1, Dr. D. Naresh2 S. Prasanna Bharathi3 1Professor and Head, Dept. of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India. 2KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India. 3KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India. ABSTRACT New method was established for simultaneous estimation of Bempedoic acid  ... Read More »

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