Author(s): Micheal Nouman

Email(s): ,

DOI: 10.52711/0974-360X.2024.00435   

Address: Micheal Nouman*
Ph.D. in Drug Control and Bio Pharmacy, Department of Pharmaceutical Technology, Faculty of Pharmacy, Al-Wataniya Private University, Syria.
*Corresponding Author

Published In:   Volume - 17,      Issue - 6,     Year - 2024

The pharmaceutical formulation stability of drug during its entire shelf life is an important matter and it is affected by many factors, one of the most important of these factors is the environmental conditions encountered during transport, storage and use. As know, the electricity access in developing countries might be a problem and the outage power may impact the stability of refrigerated pharmaceutical products. Aims: The aim of this study is to measured chemical and physical stability of dexamethasone sodium phosphate and chloramphenicol eye drops, commercially marketed as Dexachlor, stored at room temperature while the recommended condition storage is between (2-8C°). Results: After70 days of analyzing the samples, stability study revealed that storing Dexachlor?eye drops ?at 25°C does not produce any statistical difference regarding drug content, pH and clarity compared to refrigerated samples. Conclusion: Storing dexamethasone sodium phosphate and chloramphenicol eye drops at room temperature for up to 70 days appears to have no effect on the stability of this pharmaceutical product.

Cite this article:
Micheal Nouman. Study the Stability of Pharmaceutical eye drop composed of Chloramphenicol and Dexamethasone Sodium Phosphate stored in non-recommended ‎conditions. Research Journal of Pharmacy and Technology. 2024; 17(6):2773-7. doi: 10.52711/0974-360X.2024.00435

Micheal Nouman. Study the Stability of Pharmaceutical eye drop composed of Chloramphenicol and Dexamethasone Sodium Phosphate stored in non-recommended ‎conditions. Research Journal of Pharmacy and Technology. 2024; 17(6):2773-7. doi: 10.52711/0974-360X.2024.00435   Available on:

1.    Elangovan S. Effects of dexamethasone in third molar surgery, a review. Research Journal of Pharmacy and Technology. 2014; 7(11): 1354-1355.
2.    Rele R V. and Warkar C B, Simultaneous determination of ciprofloxacin hydrochloride and dexamethasone in ophthalmic solution by reversed phase high performance liquid chromatography. Asian Journal of Research in Chemistry. 2010; 3(3): 673-677.
3.    Sabale P M. Damor J S. and Chudasama G. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Sparfloxacin and Dexamethasone in Bulk and Pharmaceutical Dosage Form. Research Journal of Pharmacy and Technology. 2013; 6(7): 780-783.
4.    Singh, V D. Singh V K. and Daharwal S J. Application of Central Composite Design for screening and Optimization of HPTLC method for simultaneous quantitation of Aprepitant, Dexamethasone and Ondansetron in their synthetic mixtures. Research Journal of Pharmacy and Technology. 2021; 14(10):  5531-5539.
5.    Karajgi S. Hajeri S and Potadar S.Utilization of Hydrotropic Solubilisation Technique for Quantitative Studies of Dexamethasone in Pharmaceutical preparations. Research Journal of Pharmacy and Technology. 2022; 15(12): 5785-5788.
6.    Oong GC. Tadi P. Chloramphenicol. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing. 2023 Jan-. Available from:
7.    Mohite MT. Dudhabale V V. and. Chandgude K V. Validation of stability indicating RP-HPLC, method of analysis for assay of ivabradineHCl in SR tablet. Asian Journal of Pharmaceutical Analysis. 2019; 9(3): 133-137.
8.    Mhamunkar S M. Vyavaharkar R Y. and Bhoir S I. RP-HPLC method development and validation for the simultaneous estimation of tamsulosinHCl and tolterodine tartrate in pharmaceutical dosage form. International Journal of Pharmacy and Pharmaceutical Sciences. 2012; 4(5): 319-322.
9.    Koralla S. et al. Stability indicating RP-HPLC method for simultaneous estimation of ramipril and amlodipine besylate in pharmaceutical dosage form. Asian Journal of Pharmaceutical Research. 2016; 6(4): 242-249.
10.    Pimpale A D. and Kakde R B. Stability-indicating method development and validation for estimation of clopidogrel bisulfate in pharmaceutical dosage form by reverse-phase high-performance liquid chromatography. Asian Journal of Pharmaceutical Research. 2020; 10(4): 253-259.
11.    Chandana O S S. and. Babu R R. Stability Indicating High Performance Liquid Chromatographic Assay for the Determination of Sildenafil Tartrate. Asian Journal of Pharmaceutical Analysis. 2017; 7(3): 196-200.
12.    Loftsson T. Drug Stability for Pharmaceutical Scientists. 2014: Academic Press.
13.    Sharma T  JJ. Ketharam  M.  Herath  K. B &Shobia S S. Quality of medicines in Sri Lanka: a retrospective review of safety alerts. BMC Health Services Research. 2023; 23(1): 980.
14.    Reynolds D. et al. Available Guidance and Best Practices for Conducting Forced Degradation Studies. Pharmaceutical Technology. 2002; 26: 48-56.
15.    Matthews B R. Regulatory Aspects of Stability Testing in Europe. Drug Development and Industrial Pharmacy.1999; 25(7): 831-856.
16.    Stella S Y a V J. Stability of Drugs and Dosage Forms. 2002: Springer US.
17.    Hall  A M. Bass P and Unwin R J. Drug-induced renal Fanconi syndrome. QJM: An International Journal of Medicine. 2014;107(4): 261-269.
18.    Delfino R. Ribeiro Tand Figueroa-Villar J. Organophosphorus Compounds as Chemical Warfare Agents: a Review. Journal of The Brazilian Chemical Society – JBCS. 2009; 20.
19.    Utley D. Simultaneous determination of hydroxylamine and cyanide in formulations containing pralidoxime salts by flow injection. Analyst. 1990; 115(9): 1239-42. doi: 10.1039/an9901501239., 1990.
20.    Timothy C. Marrs  R L M. Frederick Sidell, in Chemical Warfare Agents-Toxicology and Treatment. 2007 Wiley.
21.    Akash M S H and Rehman K. Drug Stability and Chemical Kinetics. 2020.
22.    Censi R. and Di Martino P. Polymorph Impact on the Bioavailability and Stability of Poorly Soluble Drugs. Molecules (Basel, Switzerland). 2015; 20(10): 18759-18776.
23.    Fadl G. Ibrahem R andAshour M. Microbial Evaluation of Some Non-sterile Pharmaceutical Preparations Commonly Used in the Egyptian Market. Tropical Journal of Pharmaceutical Research. 2011; 10: 437-445.
24.    Liu F. et al. Patient-centred pharmaceutical design to improve acceptability of medicines: similarities and differences in paediatric and geriatric populations. Drugs. 2014; 74(16): 1871-1889. doi: 10.1007/s40265-014-0297-2., 2014.
25.    Gerhardt A H. Moisture effects on solid dosage forms--formulation, processing, and stability. 2009; 58.
26.    Cundell T. The role of water activity in the microbial stability of non-sterile drug products. European Pharmaceutical Review. 2015; 20: 58-63.
27.    Darji M A.  et al. Excipient Stability in Oral Solid Dosage Forms: A Review. AAPS Pharm. Sci. Tech. 2018; 19(1): 12-26. doi: 10.1208/s12249-017-0864-4. Epub 2017 Sep 11., 2017.
28.    Narang, A., D. Desai, and S. Badawy, Impact of Excipient Interactions on Solid Dosage Form Stability. Pharmaceutical Research. 2012; 29: 2660-83.
29.    Waterman, K.C., The application of the Accelerated Stability Assessment Program (ASAP) to quality by design (QbD) for drug product stability. AAPS Pharm. Sci. Tech. 2011. 12(3): 932-937.
30.    Porter, W., Degradation of Pharmaceutical Solids Accelerated by Changes in Both Relative Humidity and Temperature and Combined Storage Temperature and Storage Relative Humidity (TA—h) Design Space for Solid Products. 2013. 19.
31.    De Winter, S., et al., Impact of temperature exposure on stability of drugs in a real-world out-of-hospital setting. Annals of Emergency Medicine, 2013; 62(4): 380-387. e1.
32.    Blessy, M., et al., Development of forced degradation and stability Indicating Studies of drugs: A Review. Journal of Pharmaceutical Analysis, 2014; 4(3): 159-165.
33.    Ren, Z., et al., Ibuprofen degradation using a Co-doped carbon matrix derived from peat as a peroxymonosulphate activator. Environmental Research, 2021. 193: p. 110564.
34.    Crichton, B., Keep in a cool place: exposure of medicines to high temperatures in general practice during a British heatwave. Journal of the Royal Society of Medicine, 2004. 97(7): p. 328-329.
35.    Kharat, M., et al., Physical and chemical stability of curcumin in aqueous solutions and emulsions: impact of pH, temperature, and molecular environment. Journal of Agricultural and Food Chemistry, 2017; 65(8): 1525-1532.
36.    El-Shaheny, R. and K. Yamada, The influence of pH and temperature on the stability of flutamide. An HPLC investigation and identification of the degradation product by EI + -MS. RSC Adv., 2015; 5: 3206-3214.
37.    Barbosa, F.b., et al., pH effect on stability and kinetics degradation of nitazoxanide in solution. Drug Analytical Research, 2020; 4: 12-17.
38.    Ahmad, I., et al., Photostability and Photostabilization of Drugs and Drug Products. International Journal of Photoenergy. 2016. 2016: 8135608.
39.    Sánchez-Quiles, I., Review of the Stability of Photosensitive Medications. Farmaciahospitalaria, 2010. 35: p. 204-15.
40.    Won, D.H., et al., Effect of Formulation Factors and Oxygen Levels on the Stability of Aqueous Injectable Solution Containing Pemetrexed. Pharmaceutics. 2020; 6; 12(1): 46. doi: 10.3390/pharmaceutics12010046., 2020.
41.    Thanekar, P., M. Panda, and P.R. Gogate, Degradation of carbamazepine using hydrodynamic cavitation combined with advanced oxidation processes. Ultrasonics Sonochemistry, 2018. 40: 567-576.

Recomonded Articles:

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

56th percentile
Powered by  Scopus

SCImago Journal & Country Rank

Recent Articles


Not Available