Acta Pharm. 63 (2013) 385-396
Original research paper
Synthesis of the impurities during the
manufacture of bulk drug midazolam and separation of these impurities by HPLC
BHAWANA SATI, HEMLATA SATI, SARLA
SAKLANI, ELLAMMA, PRAKASH CHANDRA BHATT and RAVINESH
MISHRA
bhawanasati28@gmail.com
1 Department of
Pharmacy, Banasthali University, Banasthali, Rajasthan, India
2 Department of
Pharmaceutical Sciences, H. N. B. Garhwal University, Srinagar Garhwal,
Uttarakhand, India
3 East Point College
of Pharmacy, Bidarahalli, Virgonagar Post, Bangalore. Karnataka, India
4 Indian Medicines Pharmaceutical Corporation Ltd, Mohan, Ramnagar,
India
5 Institue of Pharmacy & Emerging Sciences, Baddi University of
Emerging Science and Technology, Makhnumajra, Baddi, Distt. Solan, Himachal
Pradesh, India
Accepted April 23, 2013
During the manufacture of bulk drug midazolam various impurities arised that can be the related products or degradation products. Structures of eight impurities that can arise during the manufacture of bulk drug midazolam were proposed. In the present work, synthesis of these impurities and their characterization by different spectroscopic techniques have been done. HPLC method was developed for the separation of impurities from the bulk drug. The developed method separates midazolam from its eight impurities/degradation products within a run time of 45 min.
Keywords: midazolam, impurities, degradation products, HPLC method