Acta Pharmaceutica, Vol. 63 No. 3, 2013.
Original scientific paper
https://doi.org/10.2478/acph-2013-0025
Synthesis of the impurities during the manufacture of bulk drug midazolam and separation of these impurities by HPLC
BHAWANA SATI
; Department of Pharmacy, Banasthali University, Banasthali, Rajasthan, India
HEMLATA SATI
; Department of Pharmaceutical Sciences, H. N. B. Garhwal University, Srinagar Garhwal, Uttarakhand, India
SARLA SAKLANI
; Department of Pharmaceutical Sciences, H. N. B. Garhwal University, Srinagar Garhwal, Uttarakhand, India
ELLAMMA
; East Point College of Pharmacy, Bidarahalli, Virgonagar Post, Bangalore. Karnataka, India
PRAKASH CHANDRA BHATT
; Indian Medicines Pharmaceutical Corporation Ltd, Mohan, Ramnagar, India
RAVINESH MISHRA
; Institue of Pharmacy & Emerging Sciences, Baddi University of Emerging Science and Technology, Makhnumajra, Baddi, Distt. Solan, Himachal Pradesh, India
Abstract
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
Hrčak ID:
102051
URI
Publication date:
30.9.2013.
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