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CHAPTER 5 REFERENCES

5. References:
1. Bolton.S, Bon.C, Pharmaceutical statistic practical &clinical application, Vol.135
(4) 273-277.
2. International Conference on Harmonization, Q7, Good Manufacturing Practice
for Active Pharmaceutical Ingredients, November 2000.
3. International Conference on Harmonization, Q1A(R2), Stability Testing
Guidelines: Stability Testing of new Drug Substances and Products, August
2003.
4. International Conference on Harmonization, Q3A(R2), Impurities in New Drug
Substances, October 2006.
5. International Conference on Harmonization, Q3B(R2), Impurities in New Drug
Products, July 2006.
6. International Conference on Harmonization, Q6A, Specifications: Test
procedures and Acceptance Criteria for New Drug Substances and New Drug
Products Chemical Substances, May 2000.
7. Bari S., Kadam B., Jaiswal Y., Shirkhedkar A., Impurity profile: Significance in
Active Pharmaceutical Ingredient, Eurasian Journal of Analytical Chemistry,
Vol. 2, 2007.
8. Ahuja S., Alsante K.M., Handbook of isolation and characterization of impurities
in pharmaceuticals, academic press, 18 – 22.
9. Remington, The science and practice of pharmacy,Vol.1 (21), 596.
10. Snyder L.R., Kirkland J.J., Dolan J.W., Introduction to modern liquid
chromatography, John Wiley & Sons,Vol 1 (3) 2010, 456-468.
11. Kurmi.M, Kumar.S, Singh.B, Singh .S, Implementation of Design of experiments
for optimization of Forced degradation conditions and development of stability
indicating Method for furosemide Journal of Pharmaceutical and Biomedical
Analysis , Vol. 96, 2014,135-143.
12. Blessy M, Patel.R, Prajapati..P, Agrawal.Y, Development of Forced Degradation
and Stability Indicating Studies of Drug review , Journal of Pharmaceutical
Analysis ,Vol. 4, 2014,159-165.
13. Kumar.J, Charde.M., Welankiwar.A, Chakole.R, Development of Forced
Degradation Studies of Drug, International Journal of Advances in
Pharmaceutics, Vol. 3, 2013, 143-149.

Sinhgad Institute of Pharmacy Narhe Pune - 4185


CHAPTER 5 REFERENCES

14. Sinko.P, Martin’s Physical Pharmacy and Pharmaceutical Science, 2006, 403-
405.
15. Nash.R , Wachter.A, Pharmaceutical Process Validation, Vol .129(3), 2003,
203-216.
16. Kim.H , Handbook of Stability testing in pharmaceutical development, Springer
publication, July 2008, 9 – 21.
17. Huber.C, Lebrun.P, Houari.S, ,Ziemon E, Rozet.E, Hubert.P, “Improvement of
SIM by QbD versus QbT”. A case of learning process ,Journal of pharmaceutical
and biomedical Analysis, Vol .2, 2013, 401-409.
18. Sonawane.S , Gide.P, Application of experimental design for optimisation of
forced degradation and development of SIM. Arabian journal of chemistry,
Vol. 6, 2012, 283-287.
19. British pharmacopoeia ,2004 validation parameters Vol.2, A-1468
20. United states pharmacopoeia ,2005,28th revision 2748
21. Hamrapurkar.P, Phale.M, Patil.P Determination of nevirapine in human plasma
by HPLC with UV Detection. International journal of pharmatech research,
Vol. 2, 2010, 1316-1324.
22. Lin, D. K, “Statistics as a catalyst to learning by scientific method-discussion,
response surface methodology: current status and future directions discussion”.
J. Quality TechnolVol.31, 1999, 61-66.
23. Lundstedt.T, Seifert.E, Abramo.L, Thelin.B, Nystrom.A, Pertensen.J,
Bergman.R. “Experimental design and optimization”. ChemomIntell. Lab. Syst.
Vol.42,1998, 3-40.
24. Ermer, J, Hans-Joachim, P, Validation in pharmaceutical analysis Part II: central
importance of precision to establish acceptance criteria and for verifying and
improving the quality of analytical data. J. Pharm. Biomed. Anal. Vol.37, 2005
859-870.
25. Araujo, P.W., Brereton, R.. G, Experimental Design-Optimization, Trends Anal.
Chem.Vol.15, 1996, 63-70.
26. Bruns, R. E, Scarminio, I. S., Neto, B.B, Statistical design- Chemometrics,
Elsevier, Amsterdam, 2006, 338-350.
27. Hockman, K.K., Berengut, D, Design of experiments, Chem. Eng.Vol.102, 1995,
142-148.

Sinhgad Institute of Pharmacy Narhe Pune - 4186


CHAPTER 5 REFERENCES

28. Fabre, H., Robustness testing in liquid chromatography and capillary


electrophoresis, J. Pharm. Biomed. Anal.Vol. 14, 1996, 1125-1132.
29. Hanrahan, G., Lui.K, Application of factorial designs and response surface
methodology in modern experimental design and optimization. Crit. Rev. Anal.
Chem. 36, 2006, 141-151.
30. Savie, I. M., Valentina D., Marinkovie, S., Lijiljana T., Dusanka K., Ivana M.,
From experimental design to quality by design in pharmaceutical legislation,
AccredQual Assur. Vol.17, 2012, 627-633.
31. Rao Prasad C.H, Channabasavaraj K.P, Development and Validation of Rp-
HPLC method for the estimation of Nevirapine in bulk drug and tablets, Journal
of Pharmaceutical Science and research Vol. 1(2), 2009,78-82.
32. Fenghe Qui, Scott Pennino, Carl.A.Bosacca, Identification of a process impurity
formed during synthesis of Nevirapine analogue HIV NNRT inhibitor, Journal of
Pharmaceutical and Biomedical Analysis, Vol. 49 , 2009 , 733-738.
33. Kaul Neeraj, Agrawal Himani, Paradkar. A.R, Mahadik K.R, HPTLC method for
determination of Nevirapine in Pharmaceutical dosage form , Talanta, Vol. 62,
2004, 843-852.
34. Mariana S.S.B, Sebastiao J.Pedro, Tavares B.Maria, 1H NMR relaxometry and
X-ray study of PCL / Nevirapine Hybrid, Polymer Testing, Vol 1 ,2013,
243-256.
35. Marchie.E, Valvo.L, Pacific.R, Simultanious determination of Zidovudine and
Nevirapine in Human plasmanby Rp-LC Vol 29, 2002, 1081-1088.
36. Badawai.M, Khordagui.K, A Quality by Design approach to optimization of
emulsion for electrospining using factorial and D- optimal design , European
Journal of Pharmaceutical Science, Vol 58, 2014, 44-54.
37. Hamrapurkar.P, Patil.P, Phale.M, Optimization and Validation of Rp-HPLC
Stability Indicating Method for determination of Efavirenz and its Degradation
product, International Journal of Applied Science and Engineering, Vol 8, 2010,
155-165.
38. Kalaria.P.D, Namdev.D, Srinivas.., Ganandhamu.S, Application of experimental
design and response surface technique for selecting the optimum RP-HPLC
conditions for moxifloxacinHCl and ketoroloactromethamines. J. Saudi Chem.
Soc. (Accepted; DOI: http://dx.doi.org/10.1016/j.jscs.2014.04.004), 2014, 58-64.

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