This document describes the development and validation of a stability-indicating RP-HPLC method to separate low levels of atoltivimab (ATO), maftivimab (MAF), and odesivimab (ODE) and other related compounds. The method uses a Sunsil C18 column with a mobile phase of NaH2PO4 and acetonitrile in a 40:60 v/v ratio. ATO elutes at 2.639 minutes, MAF elutes at 4.236 minutes, and ODE elutes at 5.620 minutes. The method was validated for parameters such as specificity, linearity, precision, accuracy, system suitability, limit of detection, limit

1. DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD TO SEPARATE LOW LEVELS OF ATOLTIVIMAB,
MAFTIVIMAB & ODESIVIMAB AND OTHER RELATED COMPOUNDS
A Dissertation submitted to
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY, HYDERABAD.
In partial fulfillment of the requirements for the award of degree of
MASTER OF PHARMACY – PHARMACEUTICAL QUALITY ASSURANCE
By
MEHER UNNISA
Hall Ticket No: 19451S1409
II yr 2nd semester M.Pharm
Under the guidance of
Dr. Syed Imam Pasha M. Pharm, PhD
In the Department of
Pharmaceutical Quality Assurance
SULTAN-UL-ULOOM COLLEGE OF PHARMACY
(Recognized by AICTE & Approved by Pharmacy Council of India)
(B-pharmacy programme accredited by NBA)
Mount Pleasant, 8-2-249 to 267, Road No. 3, Banjara Hills, Hyderabad - 500 034.
TELANGANA STATE, INDIA.
2020-21

2. Presented By: Meher Unnisa
Roll.no: 19451S1409
M.Pharmacy (Pharmaceutical Quality Assurance)
Under the guidance of: Dr. Syed Imam Pasha
Associate professor (Dept.of QA)
DEVELOPMENT AND VALIDATION OF STABILITY
INDICATING RP-HPLC METHOD TO SEPARATE
LOW LEVELS OF ATOLTIVIMAB, MAFTIVIMAB &
ODESIVIMAB AND OTHER RELATED COMPOUNDS

3. CONTENTS:
● INTRODUCTION
● AIMS & OBJECTIVES
● DRUG PROFILE
● MATERIALS & METHOD
● RESULTS & DISCUSSION
● CONCLUSION
● REFERENCES

4. ● InmazebTM has been used to treat Zaire ebolavirus infection in children & adults, notably
neonates born to a woman who has tested positive for Zaire ebolavirus contamination by
RT-PCR. InmazebTM 's effectiveness against other Ebolavirus and Marburgvirus species
has yet to be determined Severe, life-threatening responses may occur while and
following the infusion.
● Because InmazebTM may impair the efficiency of a live vaccination, it is best to avoid
giving a live vaccine while taking InmazebTM Separation & quantification of ATO,
MAF, ODE using combinational assay was carried out on column Sunsil C18 using
NaH2PO4 & Acetonitrile in 40:60v/v. ATO was eluted at 2.639 mins, MAF was eluted at
4.236 mins and ODE was eluted at 5.620 mins.The method was validated for
parameters such as specificity, linearity, precision, accuracy, system suitability, limit of
detection , limit of quantification and robustness.
INTRODUCTION

5. ● The approach described in this is relied on RP-HPLC. Mobile phase was NaH2PO4
(strength of 0.1M & pH 3.5) and acetonitrile (pure) are merged in a 40:60 vol/vol
fraction. The observations revealed a significant linear calibrating fit for ATO in the
8.335 – 25.005 µg/ml range, for MAF in the range 8.335 – 25.005 µg/ml and for ODE in
the range 8.335 – 25.005 µg/ml. LOQ was ATO – 0.196 µg/ml, MAF – 0.181 µg/ml and
ODE – 0.197 µg/ml.
INSTRUMENTATION OF RP-HPLC
INTRODUCTION

6. ❖ AIM: Quantitative estimation of drug components of Inmazeb injection.
❖ OBJECTIVES:
● Development of RP-HPLC method for simultaneous extinction of ATO, MAF, and
ODE.
● Validation of the development method for various parameters.
● Stability of the method by applying forced degradation.
AIMS & OBJECTIVES

7. ❏ Inmazeb™, Corporation: Regeneron pharmaceutical Inc., US,
❏ ( Local Source - SUN LIFE SCIENCES )
❏ Strength: ATO – 16.67 mg, MAF – 16.67 mg, and ODE – 16.67 mg.
● ATOLTIVIMAB (ATO) & MAFTIVIMAB (MAF):
Table 1: Drug profile of ATO & MAF
DRUG PROFILE
Class Monoclonal antibody Class Monoclonal antibody
Protein Formula C6448H9954N1726O2002S44 Protein Formula C6368H9886N1706O2008S46
Molecular weight 145097.54 Da Molecular weight 143948.11 Da
Half life 21 days Half life 22 days
Indicated For Ebola infection Indicated For Ebola infection

8. ➢ ATO is a completely humanised IgG1κ mAb that targets the GP1,2 glycoprotein of the
Ebola virus, particularly linking the GP1,2 glycan cap parallel to the viral site.
➢ MAF is a completely humanised IgG1κ (mAb) that targets the ebola virus GP1,2
glycoprotein, that adheres amid the GP1 and GP2 protomers there at protein's base.
● ODESIVIMAB (ODE):
Table 2: Drug profile of ODE
DRUG PROFILE
Class Monoclonal antibody
Protein Formula C6506H10024N1720O2030S42
Molecular weight 146164.54 Da
Half life 25 days
Indicated For Ebola infection

9. ➢ ODE is a completely humanised IgG1κ (mAb) that hits the ebola virus GP1,2
glycoprotein, that also attaches inside this "chalice" structure around the GP heads,
partially in touch with glycan cap.
LITERATURE REVIEW
DRUG PROFILE
LITERATURE REVIEW
Despite this clinical significance, no analytical approach for combinational assay of
atoltivimab (ATO), maftivimab (MAF), and odesivimab (ODE) has been reported in the
existing literature.

10. Table 3: Instruments used.
MATERIALS & METHODS
Instrument Model Description
RP-HPLC system 2695 Model Water alliance
Column Sunsil C18 250 mm×4.6 mm, 5µm
Software Empower Water alliance
Photodiode array detector 2998 Model Water alliance
MOBILE PHASE:
NaH2PO4 (strength of 0.1M & pH 3.5) and acetonitrile (pure) are merged in a 40:60 vol/vol
fraction.

11. Drug, chemicals and solvents: InmazebTM,Methanol (AR grade) ,Phosphoric acid, Na2HPO4
NaOH, K2HPO4 , KH2PO4, Acetonitrile, HCL and NaH2PO4
Table 4: Settings for ATO, MAF, & ODE collective assessment:
MATERIALS & METHODS
Column used Waters C18, 250 mm×4.6 mm, 5µm
Flow rate adjusted 1.0 ml/min
Injection volume adjusted 10µl
Temperature adjusted 25°C
Detector wavelength adjusted 267nm
Run time total 10 min

12. INAMAZEBTM ATO, MAF & ODE SOLUTION:
The stock InamazebTM solution was developed with ATO quantity of 166.70 μg/ml, MAF
quantity of 166.70 μg/ml and ODE quantity of 166.70 μg/ml by dissolving InamazebTM
powder having 16.67 mg of ATO, 16.67 mg of MAF and 16.67 mg of ODE in 100 ml of
dissolving solvent [NaH2PO4, strength of 0.1M & pH 3.5 and acetonitrile (pure) are merged
in a 40:60 vol/vol fraction] with 30 min sonication. Finally, a membrane filtering was applied
to filter it.Working InamazebTM solution: 5 ml stock InamazebTM solution having ATO
(166.70 μg/ml), MAF (166.70 μg/ml), & ODE (166.70 μg/ml) mixed with 45 ml dissolving
solvent [NaH2PO4, strength of 0.1M & pH 3.5 and acetonitrile (pure) are merged in a 40:60
vol/vol fraction]. Quantities: ATO – 16.67 μg/ml, MAF - 16.67 μg/ml & ODE - 16.67 μg/ml.
MATERIALS & METHODS

13. STRESS STUDIES - INMAZEBTM ATO, MAF & ODE SOLUTION:
● The stock InamazebTM solution with ATO quantity of 166.70 μg/ml, MAF quantity of
166.70 μg/ml and ODE quantity of 166.70 μg/ml was stressed consistent with ICH
directives [23] with conditions: Acid hydrolysis, Oxidation by peroxide, Base hydrolysis,
degradation through dry heat and degradation in sunlight.
● The criterion specified in the segment “SETTINGS FOR ATO, MAF, & ODE
COLLECTIVE ASSESSMENT” was used to assess the stressed sample of InamazebTM
solution completed in the above segment. The peak response and chromatograms
related to ATO, MAF, & ODE were computed. The degradation of ATO, MAF, and
ODE were evaluated in InamazebTM formulation injection based on peak response
related to ATO, MAF, & ODE obtained.
MATERIALS & METHODS

14. Table 5: Stress procedures - InamazebTM ATO, MAF & ODE solution.
Conditions applied Vol. of sample (ml) Vol. of reagent (ml) Vol. of diluent added
(ml)
Theoretical conc
(µg/ml)
Acid hydrolysis 10ml 10ml 0.1N Hcl Sonicated for 30 mins
at room temperature
and then filtered
80 ATO-16.67;
MAF-16.67;
ODE-16.67.
Base hydrolysis 10ml 10ml 0.1N NaOH Sonicated for 30 mins
at room temperature
and then filtered
80 ATO-16.67;
MAF-16.67;
ODE-16.67.
Peroxide oxidation 10ml 10ml 30% peroxide Sonicated for 30 mins
at room temperature
and then filtered
80 ATO-16.67;
MAF-16.67;
ODE-16.67.
Thermal degradation 10ml Exposed to 60°C in
oven and then filtered
Exposed to 60°C in
oven and then filtered
90 ATO-16.67;
MAF-16.67;
ODE-16.67.
Photo degradation 10ml Exposed to sunlight
for 6 hrs and then
filtered
Exposed to 60°C in
oven and then filtered
90 ATO-16.67;
MAF-16.67;
ODE-16.67.

15. RESULTS & DISCUSSION
SETTINGS FOR ATO, MAF, & ODE COLLECTIVE ASSESSMENT:
OPTIMIZATION:
Table 6 : OPTIMISED TRIAL
Mobile phase NaH2PO4 : Acetonitrile (40:60 v/v) pH 3.5
Column Waters C18, 250 mm×4.6 mm, 5µm
Flow rate 1.0 ml/min
Temperature 25°C at column and 25°C at sample
Volume 10µl
Run time 10 min
Detector 267 nm

16. RESULTS & DISCUSSION
Measurements and chromatograms
Remarks: There were three peaks (ATO, MAF and ODE) that eluted. Reasonably reduced
Rt of ATO, MAF and ODE. Reasonably acceptable system apt criteria. Used these
conditions to combinational ATO, MAF and ODE assay.

17. RESULTS & DISCUSSION
VALIDATION OF SETTINGS FOR ATO, MAF, & ODE COLLECTIVE
ASSESSMENT:
❏ LINEARITY:
ATO, MAF, & ODE calibration curves have been produced by connecting the peak areas of
ATO, MAF, & ODE to the related ATO, MAF, & ODE concentrations. Five concentration
points were utilised to create the ATO, MAF, & ODE curves. The least-square strategy was
applied to conduct regression analyses for the findings. The observations revealed a
significant linear calibrating fit for ATO in the 8.335 – 25.005 µg/ml range, for MAF in the
range 8.335 – 25.005 µg/ml and for ODE in the range 8.335 – 25.005 µg/ml.
Calibration ATO equation: y = 108514x - 3770.3, 0.9999 (R2)
Calibration MAF equation: y = 168308x – 9793, 1.0000 (R2)
Calibration ODE equation: y = 243414x - 22964, 1.0000 (R2)

18. RESULTS & DISCUSSION
Table 7: ATO, MAF, & ODE linearity.
ATO MAF ODE
µg/ml Area µg/ml Area µg/ml Area
8.335 909608 8.335 1394853 8.335 2006718
12.50 1344779 12.50 2093802 12.50 3023367
16.67 1801377 16.67 2793535 16.67 4030849
20.8375 2252932 20.8375 3495605 20.8375 5042730
25.005 2716826 25.005 4201276 25.005 6069487
Figure 1: Linearity plot of ATO.

19. RESULTS & DISCUSSION
Figure 2: Linearity plot of MAF.
Figure 3: Linearity plot of ODE.
Figure 4 : Chromatograms of ATO, MAF & ODE

20. RESULTS & DISCUSSION
LIMIT OF DETECTION:
The linearity of ATO, MAF, and ODE slope slope predictions, and also the standard
variability of ATO, MAF, and ODE area predictions, were analyzed to establish LOD.
● LOD: ATO – 0.059 µg/ml; S/N level ratio - 3.4
● LOD: MAF – 0.054 µg/ml; S/N level ratio - 3.7
● LOD: ODE – 0.059 µg/ml; S/N level ratio - 3.2
LIMIT OF QUANTIFICATION:
The linearity of ATO, MAF, and ODE slope slope predictions, and also the standard
variability of ATO, MAF, and ODE area predictions, were analyzed to establish LOQ.

21. RESULTS & DISCUSSION
● LOQ: ATO – 0.196 µg/ml; S/N level ratio – 10.6
● LOQ: MAF – 0.181 µg/ml; S/N level ratio - 3.6
● LOQ: ODE – 0.197 µg/ml; S/N level ratio – 10.1
Figure 5: Chromatograms - ATO, MAF, & ODE sensitivities.

22. RESULTS & DISCUSSION
PRECISION:
ATO (16.67 g/ml), MAF (16.67 g/ml), and
ODE (16.67 g/ml) solution concentrations
were injected six repeats in succession. The
criterion specified in the segment
“SETTINGS FOR ATO, MAF, & ODE
COLLECTIVE ASSESSMENT” was used to
assess. The SD, RSD for peak response and
chromatograms related to ATO, MAF, &
ODE were computed. The results of the tests
were quite precise for ATO, MAF, & ODE
combinational analysis.

23. RESULTS & DISCUSSION
Table 8 : ATO, MAF & ODE Precision
ATO MAF ODE
Area Data Area Data Area Data
1801450 Mean
1809572
2795385 Mean
2799158
4041713 Mean
4038800
1805448 2793510 4047817
1817891 SD
6022.899
2794882 SD
5328.907
4037978 SD
6031.993
1814119 2805079 4031317
1807220 RSD
0.333
2800566 RSD
0.190
4033187 RSD
0.149
1811301 2805524 4040789

24. RESULTS & DISCUSSION
Figure 6 : Chromatograms of ATO, MAF & ODE Precision ACCURACY:
ATO (16.67 g/ml), MAF (16.67 g/ml),
and ODE (16.67 g/ml) solution
concentrations were injected six repeats
in succession. The criterion specified in
the segment “SETTINGS FOR ATO,
MAF, & ODE COLLECTIVE
ASSESSMENT” was used to assess.
The peak response, assay and
chromatograms related to ATO, MAF,
& ODE were computed. The results of
the tests were quite accurate for ATO,
MAF, & ODE combinational analysis.

25. RESULTS & DISCUSSION
Analyzed (µg/ml) Determined (µg/ml) Assayed (%) Mean assay (%)
ATO
16.67 16.45 98.67
99.12
16.67 16.48 98.89
16.67 16.60 99.57
16.67 16.56 99.37
16.67 16.50 98.99
16.67 16.54 99.21
MAF
16.67 16.48 98.88
99.01
16.67 16.47 98.81
16.67 16.48 98.86
16.67 16.54 99.22
16.67 16.51 99.06
16.67 16.54 99.24
Table 9 : ATO, MAF & ODE Accuracy

26. RESULTS & DISCUSSION
Analyzed (µg/ml) Determined (µg/ml) Assayed (%) Mean assay (%)
ODE
16.67 16.57 99.39
99.32
16.67 16.59 99.54
16.67 16.55 99.30
16.67 16.52 99.13
16.67 16.53 99.18
16.67 16.56 99.36

27. RESULTS & DISCUSSION
Figure 7: Chromatograms - ATO, MAF, & ODE
accuracy.
RECOVERY:
Adding quantities of ATO, MAF & ODE
standards to working InamazebTM solution
with ATO quantity of 16.67 μg/ml, MAF
quantity of 16.67 μg/ml and ODE quantity of
16.67 μg/ml. Added quantities:
1. 50% recovery stage: 8.252 μg/ml each
of ATO, MAF & ODE
2. 100% recovery stage: 16.503 μg/ml each
of ATO, MAF & ODE
3. 150% recovery stage: 24.755 μg/ml each
of ATO, MAF & ODE

28. RESULTS & DISCUSSION
Area
Add in
(µg/ml)
Ascertained
(µg/ml)
Assessed
(%)
Mean assessed (%)
50% recovery stage
909729 8.252 8.31 100.66
100.68
909445 8.252 8.30 100.63
910449 8.252 8.31 100.74
100% recovery stage
1819845 16.503 16.62 100.69
100.01
1802329 16.503 16.46 99.72
1800777 16.503 16.44 99.63
150% recovery stage
2711780 24.755 24.76 100.02
100.23
2711261 24.755 24.76 100.00
2729253 24.755 24.92 100.67
Table 10: ATO recoveries.

29. RESULTS & DISCUSSION
Table 11: MAF recoveries.
Area
Add in
(µg/ml)
Ascertained
(µg/ml)
Assessed
(%)
Mean assessed (%)
50% recovery stage
1388940 8.252 8.19 99.25
99.35
1395272 8.252 8.23 99.70
1386625 8.252 8.18 99.08
100% recovery stage
2805472 16.503 16.54 100.24
99.96
2797402 16.503 16.49 99.95
2790595 16.503 16.45 99.70
150% recovery stage
4207723 24.755 24.81 100.22
100.26
4213566 24.755 24.84 100.36
4205817 24.755 24.80 100.18

30. RESULTS & DISCUSSION
Table 12: ODE recoveries.
Area
Add in
(µg/ml)
Ascertained
(µg/ml)
Assessed
(%)
Mean assessed (%)
50% recovery stage
2001828 8.252 8.21 99.45
99.79
2017925 8.252 8.27 100.25
2006241 8.252 8.22 99.67
100% recovery stage
4039731 16.503 16.56 100.34
100.30
4040310 16.503 16.56 100.36
4034285 16.503 16.54 100.21
150% recovery stage
6065089 24.755 24.86 100.43
100.46
6060060 24.755 24.84 100.35
6075930 24.755 24.91 100.61

31. RESULTS & DISCUSSION
Figure 8: Chromatogram of ATO recovery. Figure 9: Chromatograms of MAF recovery.

32. RESULTS & DISCUSSION
ROBUSTNESS: Chromatographic settings
were:Proportion of acetonitrile, Value of pH,
Detector nanometres, Rate flow stream, Set
column temperature.Robustness was tried
with ATO, MAF & ODE standard solution
with ATO quantity of 16.67 μg/ml, MAF
quantity of 16.67 μg/ml and ODE quantity of
16.67 μg/ml. The peak response,
chromatographic equipment suitability
profile and chromatograms related to ATO,
MAF, & ODE were computed. The results of
the tests were quite robust for ATO, MAF, &
ODE combinational analysis.
Figure 10: Chromatograms of ODE recovery.

33. RESULTS & DISCUSSION
Figure 11: Chromatograms - ATO, MAF, & ODE robustness (acetonitrile).

34. RESULTS & DISCUSSION
Figure 12: Chromatograms - ATO, MAF, & ODE robustness (flow stream).

35. RESULTS & DISCUSSION
Figure 13: Chromatograms - ATO, MAF, & ODE robustness (detection nm).

36. RESULTS & DISCUSSION
Figure 14: Chromatograms - ATO, MAF, & ODE robustness (value of pH).

37. RESULTS & DISCUSSION
Figure 15: Chromatograms - ATO, MAF, & ODE robustness (temperature).

38. RESULTS & DISCUSSION
DEGRADATION STUDIES:
The stock InamazebTM solution with ATO quantity of 166.70 μg/ml, MAF quantity of 166.70
μg/ml and ODE quantity of 166.70 μg/ml was stressed consistent with ICH directives with
conditions: Acid Hydrolysis, Oxidation by peroxide, Base hydrolysis, Degradation through
dry heat and degradation in sunlight.
The findings of the assessment are displayed in the table following:
ATO stability:
105 oC > HCl (0.1 N) > H2O2 (30%) > NaOH (0.1 N) > light
MAF stability:
HCl (0.1 N) > 105 oC > NaOH (0.1 N) > H2O2 (30%) > light
ODE stability:
HCl (0.1 N) > 105 oC > NaOH (0.1 N) > light > H2O2 (30%)

39. RESULTS & DISCUSSION
Condition Area Drug remained Drug degraded
ATO
Peroxide 1665970 91.25 8.75
Acid 1657614 90.79 9.21
Sun light 1699231 93.07 6.93
Alkali 1683216 92.20 7.8
Thermal 1637250 89.68 10.32
MAF
Peroxide 2640371 93.39 6.61
Acid 2533352 89.61 10.39
Sun light 2677798 94.72 5.28
Alkali 2576889 91.15 8.85
Thermal 2561804 90.61 9.39
ODE
Peroxide 3859963 94.92 5.08
Acid 3652703 89.82 10.18
Alkali 3750611 92.23 7.77
Sun light 3799085 93.42 6.58
Thermal 3683158 90.57 9.43
Table 13: Degradation outcomes of DRE, LDE and TFE.

40. RESULTS & DISCUSSION
Figure 16: Chromatograms - ATO, MAF, & ODE degradation.

41. RESULTS & DISCUSSION
Stress breakdown compounds were not
detected among any of the LDE, DRE, or
TFE retention periods. The results of the tests
were quite specific and stability indicating for
ATO, MAF, & ODE combinational analysis.
SELECTIVITY: InamazebTM solution with
ATO quantity of 16.67 μg/ml, MAF quantity
of 16.67 μg/ml and ODE quantity of 16.67
μg/ml, diluent [NaH2PO4, strength of 0.1M &
pH 3.5 and acetonitrile (pure) are merged in a
40:60 vol/vol fraction] and Working ATO,
MAF & ODE solution with ATO quantity of
16.67 μg/ml, MAF quantity of 16.67 μg/ml
and ODE quantity of 16.67 μg/ml were
analysed by criterion specified in the segment
“SETTINGS FOR ATO, MAF, & ODE
COLLECTIVE ASSESSMENT”.

42. RESULTS & DISCUSSION
Figure 17: Chromatograms - ATO, MAF, & ODE selectivity.

43. CONCLUSION
Within this project, I devised a simultaneous combinational technique for inmazeb injection
that included ATO, MAF, and ODE. The approach described in this is relied on RP-HPLC.
The combinational technique for inmazeb injection that included ATO, MAF, and ODE was
optimised and found having efficient, linear, reliable, robust, stability indicating and
sensitivity measurement of ATO, MAF, and ODE in combination in inmazeb injection.

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46. Thanks!
Meher Unnisa
Roll.no: 19451S1409
M.Pharm (QA)
e-mail: Meher.alam26@gmail.com