CHAPTER 5 REFERENCES

5. References:
 Ahuja S., Alsante K. Handbook of isolation and characterization of impurities in
pharmaceuticals. academic press.18 – 22.
 Anandgaonkar V.,Gupta A., Srinivas K., Talluri K. (2014). Isolation LC-MS/MS
and 2D-NMR characterization of alkaline degradants of Tenofovir disoproxil
fumarate. Journal of Pharmaceutical and Biomedical Analysis.7085-8015.
 Araujo P., Brereton, R. (1996). Experimental Design-Optimization. Trends
Analytical Chemistry. 63-70.
 Badawai. M, Khordagui. K. (2014). A Quality by Design approach to
optimization of emulsion for electrospining using factorial and D- optimal
design . European Journal of Pharmaceutical Science. 44-54.
 Baig M., Dehghan M. (2015). Stability-Indicating HPTLC Method development
and validation for Analysis of Lamivudine and Tenofovir from its Tablet Dosage
Form. Journal of Medicinal Chemistry and Drug Discovery. 463-474.
 Bari S., Kadam B., Jaiswal Y., Shirkhedkar A. (2007). Impurity profile:
Significance in Active Pharmaceutical Ingredient. Eurasian Journal of Analytical
Chemistry. 2.
 Bhutani H., Kurmi M.,Singh S., Beg S., Singh B. (2014). Quality by Design
(QbD) in Analytical Sciences: An Overview. Pharma Times. 46(08). 71-75
 Blessy M., Patel R., Prajapati P., Agrawal Y. (2014). Development of Forced
Degradation and Stability Indicating Studies of Drug review. Journal of
Pharmaceutical Analysis. 4.159-165.
 Bolton S., Bon C. Pharmaceutical statistic practical &clinical application. 135 (4)
273-277.
 British pharmacopoeia. (2004). validation parameters .2. A-1468.
 Bruns R., Scarminio I., Neto B. (2006). Statistical design- Chemometrics,
Elsevier. Amsterdam. 338-350.
 Devrukhakar P., Borkar R., Shastri N., Surendranath K.V. (2012). A Validated
Stability-Indicating RP-HPLC Method for the Simultaneous Determination of
Tenofovir, Emtricitabine, and a Efavirenz and Statistical Approach to Determine
the Effect of Variables. ISRN Chromatography. 1-8.
 Divya B., Thangabalan B. (2015). Method development and validation for
simultaneous estimation of tenofovir disoproxil fumarate and lamivudine in

Sinhgad Institute of Pharmacy Narhe Pune - 4187

CHAPTER 5 REFERENCES

combined tablet dosage form by RP-HPLC. World journal of Pharmacy and

Pharmaceutical sciences. 4(6),. 1396-1403.
 Ermer J., Hans-Joachim P. (2005). Validation in pharmaceutical analysis Part II:
central importance of precision to establish acceptance criteria and for verifying
and improving the quality of analytical data. Journal of Pharmaceutical and
Biomedical Anaysis.37. 859-870.
 Fabre H. (1996). Robustness testing in liquid chromatography and capillary
electrophoresis, Journal of Pharmaceutical Biomedical Analysis. 14. 1125-1132.
 Gandhi B., Rao A., Rao J. (2015). Method Development and Validation by RP-
HPLC for Simultaneous Estimation of Emtricitabine and Tenofovir Disoproxil
Fumarate. World Journal of Pharmacy and Pharmaceutical Sciences. 4(7). 859-
873.
 Golla V., Kurmi M., Shaik K., Singh S. (2016). Stability behaviour of
antiretroviral drugs and their combinations. 4: Characterization of degradation
products of tenofovir alafenamide fumarate and comparison of its degradation
and stability behaviour with tenofovir disoproxil fumarate. Journal of
Pharmaceutical and Biomedical Analysis. 131. 146-155.
 Hanrahan G., Lui K. (2006). Application of factorial designs and response
surface methodology in modern experimental design and optimization. Critical
Review Analytical chemistry. 36. 141-151.
 Havele S., Dhaneshwar S. (2012). Development and validation of a stability-
indicating LC method for the determination of Tenofovir disoproxil fumarate in
pharmaceutical formulation, Journal of Science and Technology, Vol.34 (6), 615-
622.
 Hockman K., Berengut D. (1995). Design of experiments. Chemical Engineering.
102. 142-148.
 Huber C., Lebrun P., Houari S., Ziemon E., Rozet E., Hubert P.(2013).
Improvement of SIM by QbD versus QbT. A case of learning process. Journal of
pharmaceutical and Biomedical Analysis. 2.401-409.
 International Conference on Harmonization. (2000). Q7. Good Manufacturing
Practice for Active Pharmaceutical Ingredients.
 International Conference on Harmonization. (2003). Q1A (R2). Stability Testing
Guidelines: Stability testing of new Drug Substances and Products.

Sinhgad Institute of Pharmacy Narhe Pune - 4188

CHAPTER 5 REFERENCES

 International Conference on Harmonization. (2006). Q3A (R2). Impurities in

New Drug Substances.
 International Conference on Harmonization. (2006). Q3B (R2). Impurities in
New Drug Products.
 International Conference on Harmonization. (2000). Q6A. Specifications: Test
procedures and Acceptance Criteria for New Drug Substances and New Drug
Products Chemical Substances.
 Kim H. (2008). Handbook of Stability testing in pharmaceutical development.
Springer publication. 9 – 21.
 Komaroju D., Reddy G., Dhanalakshmi K. (2013). Method Development and
Validation for Simultaneous Estimation of Emtricitabine and Tenofovir
Disoproxil Fumarate in Pure and Tablet Dosage Form by using RP-HPLC.
International Journal of Pharmaceutical Research & Review. 2(10).1-11.
 Kurmi M., Kushwah B., Sahu A., Narayanam M., Singh S. (2015). Stability
behaviour of antiretroviral drugs and their combinations. 1: characterization of
tenofovir disoproxil fumarate degradation products by mass spectrometry. RSC
Advances. Royal Society of Chemistry. 5(116).96117-96129
 Kurmi M., Kushwah B., Sahu A., Narayanam M., Singh S. (2016). Stability
behaviour of antiretroviral drugs and their combinations. 2: Characterization of
interaction products of lamivudine and tenofovir disoproxil fumarate by mass and
NMR spectrometry. Journal of pharmaceutical and biomedical analysis.125. 245-
259.
 Kurmi M., Singh D.K., Tiwari S., Sharma P., Singh S. (2016). Stability
behaviour of antiretroviral drugs and their combinations.3: Characterization of
interaction products of emtricitabine and Tenofovir disoproxil fumarate by mass
spectrometry. Journal of Pharmaceutical and Biomedical Analysis.128. 438-446.
 Kurmi M., Kumar S., Singh B., Singh S. (2014). 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 .96.135-143.
 Kumar J., Charde M., Welankiwar A., Chakole R. (2013). Development of
Forced Degradation Studies of Drug. International Journal of Advances in
Pharmaceutics. 3. 143-149.

Sinhgad Institute of Pharmacy Narhe Pune - 4189

CHAPTER 5 REFERENCES

 Lin D. (1999). Statistics as a catalyst to learning by scientific method-discussion,

response surface methodology: current status and future directions discussion.
Journal of Quality Technology. 31. 61-66.
 Lundstedt T., Seifert E., Abramo L., Thelin B., Nystrom A., Pertensen J. (1998).
Experimental design and optimization. Chemom Intell. Lab. Syst.42. 3-40.
 Remington, The science and practice of pharmacy.1 (21). 596.
 Sinko.P, Martin’s Physical Pharmacy and Pharmaceutical Science. (2006). 403-
405.
 Sonawane S., Gide P. (2012). Application of experimental design for
optimisation of forced degradation and development of SIM. Arabian journal of
chemistry. 6. 283-287.
 Sutar S., Kadam A., Bandgar S.,Patil S.,Pishvikar S., More H.(2013).
Development of High Performance liquid chromatography method for
determination of Tenofovir disoproxil fumarate and It’s degraded products
formed under Stress condition. International Journal of Advances in
Pharmaceutical Research.4 (10). 2407 – 2413.
 Syed S., Shenoyb P., Muddu K. (2013). Development and Validation of Stability
Indicating RP-HPLC method for Tenofovir Nanoparticle Formulation.
International Journal of Pharmacy and Pharmaceutical Sciences. 5(2). 0975-1491
 United states pharmacopoeia (2005) .28th revision 2748
 Valli P., Reddy B.,Rao S., Golkonda R., Dittakavi R. (2015). Stability Indicating
RP-UPLC Method for Assay of Emtricitabine and Tenofovir Disoproxil
Fumarate in Bulk and Dosage Forms. American Journal of Analytical Chemistry.
6. 807-821
 Vanaja P., Anusha N., Giri S. (2013), Development and Validation of a RP-
HPLC method for Simultaneous estimation of lamivudine, Tenofovir disoproxil
fumarate and Efavirenz in a combined tablet dosage form. International Journal
of Pharmacy and Pharmaceutical sciences. 5(3). 116-121
 Yadav M., Mishra1 T., Singhal P., Goswami S., Shrivastav P. (2009 ). Rapid and
Specific Liquid Chromatographic Tandem Mass Spectrometric Determination of
Tenofovir in Human Plasma and its Fragmentation Study. Journal of
Chromatographic Science. 47.141-148

Sinhgad Institute of Pharmacy Narhe Pune - 4190