Investigation on Effect of Stress on Dissolution Stability of Drug Product by Applying Thermal and NonThermal Methods of Analysis

Main Article Content

Krishna R. Gupta
Rahul P. Chaudhari
Anita R. Pounikar
Anvesha V. Ganorkar


Aim: The aim of the research work has to development and validation of dissolution test method for Tapentadol using HPLC method, investigate the effects of stress on dissolution stability by thermal and non-thermal methods. The present research work mainly focused on the evaluation and compares the influence of accelerated-aging conditions on the drug content and in vitro dissolution stability.

Place and duration of Study: Department of Pharmaceutical Chemistry, Smt. Kishoritai Bhoyar College of Pharmacy, New Kamptee, Nagpur (MS).

Methodology and Results: Saturated solubility study of tapentadol were carried out using different dissolution media and different conditions such as type of dissolution medium, volume of dissolution medium and rotation speed of paddle were evaluated. Basis of it, dissolution testing were carried out on a suitably calibrated USP Apparatus II (TDT-06L) at 50 ± 1 rpm, under sink conditions in 900 mL of deaerated distilled water at 37±0.5ºC for each test and selected most optimized dissolution parameter  which given maximum % release of drug. The drug release was evaluated by high-performance liquid chromatographic method. Also proposed method were validated as per ICH guidelines with respect to system suitability, linearity, precision, accuracy, range,  robustness, ruggedness and solution stability parameters were evaluated  and the obtained results were within the acceptable range. The stress on dissolution stability of standard powdered drug, tablet formulation and packed strip formulation were investigated by using thermal and non thermal methods. The results obtained in all stress conditions such as thermal, humidity, UV light and visible light were evaluated for drug content and drug release. The results were statistically evaluated by applying two-way ANOVA followed by post-hoc Bonferroni test and their results represented as a graphical plot.

Conclusion: In our investigation of stress dissolution of drug it was found that Tapentadol HCl std. drug was susceptible to degradation. The tablet and packaged formulation were susceptible to photolytic degradation indicated by difference in drug content while the release was more affected under UV exposed to tablet and strip packaged formulation as compared to other stress conditions.

Tapentadol dissolution method, stress studies, thermal and non-thermal methods, ANOVA design

Article Details

How to Cite
Gupta, K. R., Chaudhari, R. P., Pounikar, A. R., & Ganorkar, A. (2019). Investigation on Effect of Stress on Dissolution Stability of Drug Product by Applying Thermal and NonThermal Methods of Analysis. Asian Journal of Applied Chemistry Research, 4(1), 1-20.
Original Research Article


The Merck Index, 15th Eds. A Subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.

Singh DR, Nag K, Shetti AN, Krishnaveni N. Tapentadol Hydrochloride: A Novel Analgesic. Saudi Journal of Anaesthesia. 2013;7(3):322.
DOI: 10.4103/1658-354X.115319

Kayesh R, Hasan S, Sultan Z. A novel RP-HPLC Method for Quantification of Tapentadol HCl In Pharmaceutical Formulations. Der Pharma Chem. 2013;5: 94-100.

Tapentadol, Pre-review Report. Expert Committee on Drug Dependence. Hammamet, Tunisia, World Health Organization (WHO); 2012.
Avaiable: Date of access: September 09, 2015.

Vidal NL, Brevedan MI, Varillas MA, Simionato LD, Pizzorno MT. Effect of Accelerated-aging Conditions on the Dissolution Stability of Ciprofloxacin Tablets. Dissolution Technologies. 2010: 23-9.

Saville DJ. Influence of Storage on In-vitro Release of Ibuprofen from Sugar Coated Tablets. International Journal of Pharmaceutics.2001;224(1-2):39-49. Avaiable:

Pandit JK, Tripathi MK, Babu JR. Effects of Disintegrants on the Dissolution Stability of Solid Oral Dosage Forms. Pharmazie. 1997;52:538-40.

Matthews BR. Regulatory Aspects of Stability Testing in Europe. Drug Development and Industrial Pharmacy. 1999;25(7):831-56.

Bourland JA, Collins AA, Chester SA, Ramachandran S, Backer RC. Determination of Tapentadol (Nucynta®) and N-desmethyltapentadol in Authentic Urine Specimens by Ultra-Performance Liquid Chromatography-Tandem Mass Spectrometry. Journal of Analytical Toxicology. 2010;34(8):450-7.

Bhatasana PT, Parmar AR. Development and Validation of RP-HPLC Method for Estimation of Tapentadol Hydrochloride in its Tablet Dosage Form. Der Pharma Sinica.2012;3(697):422-26.

Muzib YI, Reddy JR, Chowdary KP, Swathi E. Development and validation of RP-HPLC Method for Estimation of Tapentadol Hydrochloride in Bulk and Tablet Dosage Forms. International Journal of Chemical and Analytical Science. 2013;4(2):67-72. Avaiable:

Kanzariya RP, Patel TP, Kapuriya KG, Faldu SD. Method Development and Validation of Tapentadol Hydrochloride by RP-HPLC Method. Inventi Rapid: Pharm Ana & Qual Assur; 2012.

Kale KN, Gupta KR. Development and validation of stability indicating RP- HPLC method for determination of Tapentadol in Bulk and Pharmaceutical Dosage Forms,, 2015;5(4):237-245.

Giorgi M, Meizler A, Mills PC. Quantification of Tapentadol in Canine Plasma by HPLC with Spectrofluorimetric Detection: Development and Validation of a New Methodology. Journal of Pharmaceutical and Biomedical Analysis. 2012;67:148-53.

Kathirvel S, Satyanarayana SV, Devalarao G. Application of a Validated Stability-Indicating LC Method for the Simultaneous Estimation of Tapentadol and its Process-related Impurities in Bulk and its Dosage Form. Journal of Chemistry. 2012;2013. Avaiable:

Anumolu PD, Haripriya A, Sirisha N, Venkat Raju Y, Sunitha G, Rao V. Original Research Article Stability Indicating Spectrofluorimetric Quantification Of Tapentadol HCl And Application To In-Vitro Dissolution Studies.

ICH Harmonised Tripartite Guideline, Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances, Q6A .1999:10- 11.

Vaghela B, Kayastha R, Bhatt N, Pathak N and Rathod D. Development and validation of Dissolution Procedures. J Appl Pharm Sci. 2011;1(3): 50-56.

Bajaj S, Singla D, SakhujaN., Stability Testing of Pharmaceutical Products, Journal of Applied Pharmaceutical Science. 2012;02 (03):129-138.