Академический Документы
Профессиональный Документы
Культура Документы
TABTE OF CONTENTS
Serial No. Contents Page No.
1, Purpose 03
2 Objective 03
3 Scope 03
4 Materials, Reagent and Column 03
4.1 Primary material 03
4.2 Regents 03
4.3 Column 03
5 lnstrument Qualification 03
1. Purpose: The purpose of this report is to validate the analytical method for assay of Asmatab Tablet.
2. Objective: The objective of this report is to give the evidence of the validity of the method for assay of Asmatab Tablet.
3. Scope: To evaluate the acceptability of analytical method for its intended purpose. lt will define the procedure,
documentation, references and acceptance criteria to be used in the validation of assay method of Asmatab Tablet.
4. MATERIALS, REAGENT AND EQUIPMENTS
4.l PRIMARY MATERIAL
Sr. No. Name Source Descriotion
01 Asmatab Tablet Veritas Pharmaceuticals Ltd, Tvpe Finished Product
Bangladesh Batch No. 402003
Shelf life 03 years
o2 Montelukast Sodium Morepen Lab Ltd. lndia Tvoe Workine Standard
Batch No. MtT-3013
Shelf life July 2074
4.2 REAGENT
Sr. No. Reasent Name Manufacture Batch No. Shelf Life
01 Ammonium Acetate Sharlau, Spain 11934801 August 2015
02 Glacial Acetic Acid Active Fine Chemicals Ltd. BD GAAGR I2O5OO2 April2015
03 Methanol Active Fine Chemicals Ltd. BD Melhe 1307013 June 2016
4.3 Column
Sr. No. Description ID
01 Kromacil 100-C18 HD, l-50 x4.6 mm, 5p or Equivalent QCHC- 010
Sr. lnstrument Brief Description QAD No. Calibration Record Doc. No.
No. Name
01 HPLC . PerkinElmer Flexar QC-LC-o1 Date of Calibration 09.03.14 VPL/QC/QC-
HPLC integrated Next due date 08.04.14 LC-01/001
with PDA detector Calibration done by Md. Masud Rana
02 Analytical BOECO Electronic QC-AB-18 Date of Calibration 03.o2.t4 VPL/QC/QC-
Balance Balance Next due date 02.o8.74 AB-0u018
Calibration done by Md. Mizanur Rahman
6.1 Accuracy
Acceptance criteria: Average recovery at each level within 98% lo 102% and RSD value of nine determinations must
be less lhan 2%.
/
.(
Result: Complies 1 Not Complies
Data Attached
6.2 Precision
5.2.1 Repeatability (Method Precision)
Result:
1 99.21
2 100.33
3 99.03
99.51 0.62 0.62
4 100.26
5 99.19
6 99.02
Acceptancp criteria: RSD of the active contents of six samples must be less than 2%.
/
Result: {Complies 1 Not Complies
Data Attached
Analyst 1 Analyst 2
Done By Farhana Sultana Md. Mizanur Rahman
Location QC Lab QC Lab
lnstrumenl
Used HPLC HPLC
Date of
Analysis 27.O3.t4 28.03.14
Label spl Mean Label spl
Assay% STDEV RSD%
Mean
Claim% No. Assay% Assay% STDEV RSD%
Claimo/o No. Assay%
t 99.21 t 99.5
2 100,33 2 100.4
3 99.03 3 99.0
100 99.51 0.62 0.62 100
4 L00.26 99.61 0.72 0.72
4 98.9
5 99.19 5 99.1
6 99.O2 6 100.6
Acceptance criteria: RSD of the active contents of six samples must be less than 2yo.asper Repeatability day 1.
Remarks: iEl'Compl ies EI Not Complies
Data Attached
6.3 Linearity
213238.0 0
140
0.05 0.1 0.15
Montelukast
Acceptance criteria: The calibration curve should be linear (visually) and the value of R2 must be > 0.99
Remarks: Gomplies ElNot Complies
Range:
6.4 Specificity
Acceptance criteria: There will be no interference at the peak region of Montelukast due to Placebo/Blank
solution.
,/
Remarks: 'f Complies 'l Not Complies
Data Attached
6.5 Sensitivity
lnjection
Tailing Factor Retention Time (min.) Area Theoretical Plate Count
No.
1 1.35 4.933 972070.5 1868
2 1.366 4.924 979045,8 1.904
3 1.36 4.922 974558.1 1902
4 1..376 4.922 974395,1 L920
5 1..376 4.920 973842.6 1905
6 L.372 4.933 9729s2.9 1915
Avg. (n = 6) 1.37 4.93 974477.5A 1902
% RSD 0.7s o.12 o.2s 0.96
Limit: NMT 2 RSD%: NMT 2.0% RSD%: NMT 2.0% NLT 15OO
./'
Remarks: VComplies 1 Not Complies
Data Attached
7. DEVIATION: No deviation"
8. REPORT
ment : Product
Product Name : Asmatab Tablet
Summary & Discussion ;
The data collected so far suggests that method is suitable and there is no significant change with respect to the established
limits.
Conclusion & Recommendation :
Based on this it is concluded that this method can be assiqned as Analvtical method for the assav of Asmatab Tablet.
Prepared by:
Signature : Furtwq
Date : 2s ta\ J lv1
Checked by:
Signature:
Date : Leri ,/n<,4a
Approved by:
Signature
Date
9. Revision History
Sl. No. Version & lssue details Revision/Change in brief Reason for change