Thursday , 22 February 2024

Tag Archives: QbD

Regulatory Requirement for the Quality Improvement Plan for a Stabilized Product Development

Nandini Ramani*, Y. Sai Phanendra, G. Sirisha, Doonaboyina Ragava, Kavala Nageswara Rao Department of Pharmaceutical Drug Regulatory Affairs, K. G. R. L College of Pharmacy, Bhimavaram-534201, A.P, India A B S T R A C T The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. ... Read More »

Validation of Stability Indicating RP-HPLC Method for the Simultaneous Estimation of Pregabalin and Methylcobalamin in Formulation by QBD Approach

Aasadi Balaji*, G. Dharmamoorthy, G. Aruna, KV Nanda Kumar, P. Jaya Chandra Reddy Krishna Teja Pharmacy College, Chadalawada Nagar, Renigunta Road Tirupati-517506 ABSTRACT By considering the current regulatory requirement for an analytical method development, a simple, precise, accurate, linear and rapid Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method for the simultaneous quantitative estimation of Pregabalin 75mg and Methylocobalamin 750µg ... Read More »

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