Factorial Approach for the development of stability indicating HPLC assay of recombinant human insulin: Application to its stability study

RN Dash, M Habibuddin, A Sahoo… - Current …, 2013 - ingentaconnect.com
This paper describes the development and validation of a most economical and sensitive
isocratic stability indicating HPLC method for the assay of recombinant human insulin (RHI) …

[PDF][PDF] Development of RP Development of RP-HPLC for Analysis of Human-HPLC for Analysis of Human Insulin

DS Rajan, KV Gowda, U Mandal… - Indian journal of …, 2006 - academia.edu
T he objective of the present work is to develop a simple and sensitive method for analysis of
human insulin injection by using reverse-phase high performance liquid chromatography …

A validated RP‐HPLC method for the determination of recombinant human insulin in bulk and pharmaceutical dosage form

BA Moussa, F Farouk, HME Azzazy - Journal of Chemistry, 2010 - Wiley Online Library
A modified RP‐HPLC method was developed for the quantitative determination of
recombinant human insulin in bulk and pharmaceutical dosage form with reduced retention …

Development, optimisation, validation and inter-laboratory verification of a reversed phase HPLC method for quantification of human recombinant insulin

A Iyrie, C Russell, T Dennision, R Rajoli… - … of Advances in …, 2018 - research.aston.ac.uk
HPLC methods for insulin in official monographs require extended runtimes and elevated
temperatures. Inter-laboratory reproducibility of HPLC methods obtained from published …

[PDF][PDF] Development and validation of simple and rapid high performance liquid chromatographic method for routine analysis of human insulin in formulations

MJ Ansari, S Jamil, MK Anwer… - Afr J Pharm …, 2014 - academicjournals.org
A simple, specific, precise and accurate reversed phase liquid chromatographic (RP-LC)
method has been developed for determination of insulin in dosage form. The …

A rapid, isocratic HPLC method for determination of insulin and its degradation product

A Najjar, M Alawi, N AbuHeshmeh… - Advances in …, 2014 - Wiley Online Library
This paper aimed to develop a simple, sensitive, and rapid chromatographic procedure for
the simultaneous analysis of human insulin and its main decomposition product using …

Insulin evaluation in pharmaceuticals: variables in RP-HPLC and method validation

LI Salem, MC Bedmar, MM Medina… - Journal of Liquid …, 1993 - Taylor & Francis
In this paper different factors, including solvent composition, pH, flow rate, temperature and
organic modifier volatility, were examined for their effects on the resolution of Insulin by …

Accelerated stability testing of proteins and peptides: pH-stability profile of insulinotropin using traditional Arrhenius and non-linear fitting analysis

GF Stamper, WJ Lambert - Drug development and industrial …, 1995 - Taylor & Francis
The stability of insulinotropin was evaluated as a function of pH and temperature in the
present study so as to predict stability at ambient and subambient temperatures. For …

Less is more: Validating a single method for comprehensive rh-insulin analysis

S Mendiratta, G Bindra, S Singh, P Katoch… - … of Pharmaceutical and …, 2024 - Elsevier
The objective of this current study is to establish a single method for potency and related
proteins analysis of human insulin formulations using reverse-phase high performance …

Evaluation of non-isothermal methods in stability studies of human insulin pharmaceutical preparations

A Oliva, M Suárez, JR Hernández, M Llabrés… - … of pharmaceutical and …, 2009 - Elsevier
The purpose of this research was to study the thermal stability of a human insulin
pharmaceutical preparation using non-isothermal conditions and comparison with classical …