Agilent Case Study:

A Conversation with
Dr. A. Siva Lakshmi Deviof Laurus Labs

Trace-Level Quantification of Mutagenic Nitrosamine
Impurities
Dr. A. Siva Lakshmi Devi is the Assistant Vice President and Head of ADGenerics at Laurus Labs of Hyderabad, India. A pharmaceuticals industry
professional for nearly 20 years, she has expertise in solid-state and impurity
characterization, encompassing advanced analytical techniques such as
LC/MS/MS, GC/MS/MS, NMR, and XRD.
Dr. Devi has been using an Agilent 6470 LC/TQ in her lab for more than 18months to perform trace-level quantification of potential genotoxic impurities inAPIs and formulation products, which are analyzed to ensure the quality andsafety of pharmaceuticals. She recently spoke with Agilent about herexperiences using the 6470 LC/TQ.

Agilent: Describe some of the analytical challenges faced by thepharma industry today, and what your lab has done to addressthese challenges.
Dr. Devi: With increasing regulatory requirements, and to help ensure
safe products, today’s analytical labs have to deliver highly sensitive andreproducible results. Our major focus is to support quantitative LC/MS/MS
method development for the analysis of N-nitrosamine impurities in various
APIs and formulations at very low levels. To achieve this, I wanted to have atriple quadrupole mass spectrometer in our laboratory, which I felt was theinstrument that best matched our analytical requirements.

Dr. A. Siva Lakshmi Devi
Assistant Vice President and Head of AD-Generics
Laurus Labs, Hyderabad, India

Agilent: How have the Agilent team and the 6470 LC/TQ helped
you achieve your goals?
Dr. Devi: We approached the Agilent team to discuss instrumentation options
and how the latest technological advantages of their triple quadrupole mass
spectrometers addressed our needs. Agilent has developed quantitative
workflows that enable highly sensitive quantification of N-nitrosamine invarious challenging APIs and formulation products using their 6470 LC/TQ,
which can deliver detection limits even lower than those specified by theregulatory requirements. We made the decision to purchase an Agilent 6470
LC/TQ, and the Agilent team supported us with successful installation of
the instrument and in-depth familiarization with the software and hardwarefeatures – all the necessary handholding we needed to become familiar withthe instrument and get up to speed with our analysis.

"Agilent has developed quantitative
workflows that enable highly sensitive
quantification of N-nitrosamine invarious challenging APIs andformulation products using their 6470
LC/TQ, which can deliver detection
limits even lower than those specified
by the regulatory requirements.”

Dr. A. Siva Lakshmi Devi

Agilent: Has the 6470 LC/TQ met your expectations?
Dr. Devi: I am happy with Agilent 6470 LC/TQ – the lowest LOD and LOQ
levels are easily achievable, as baseline noise is minimal and stable.
In addition to sensitivity, it’s important to have an instrument that is stable andrequires minimal maintenance during daily operations, so that the downtime
can be reduced. The 6470 in our lab has been running for more than a yearand half, and we have successfully developed and transferred highly sensitive
LC/MS/MS methods for N-nitrosamine and other genotoxic impurities. The
solution includes a client-server based data management platform (OpenLabECM) that provides technical controls to securely acquire, process, report, andstore data in accordance with the data integrity and compliance guidelines ofUS FDA 21 CFR Part 11.
In addition, I am happy with the on-time application and service support
provided by Agilent. They have always been there to help us to meet ourproject timelines.

See how an Agilent LC/MS/MS system can help further yourdrug discovery and development success.
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DE16460492
This information is subject to change without notice.
© Agilent Technologies, Inc. 2022
Published in the INDIA, April 25, 2022
5994-4933ENIN

Figure 1. Agilent 6470B triple quadrupole LC/MS.