Asian Journal of Pharmaceutical Analysis

ISSN

2231-5675 (Online)
2231-5667 (Print)


Submit Article

Critical Parameters affecting Stability of APIs and Drug Products: A Review

Author(s): Bhagyashree Tayade, Vikram Gharge, Balasaheb Jadhav, Anant Patil, Chetan Parde, Shraddha Patil

Email(s): Vikram.gharge@zuventus.com

DOI: 10.52711/2231-5675.2026.00007

Address: Bhagyashree Tayade, Vikram Gharge*, Balasaheb Jadhav, Anant Patil, Chetan Parde, Shraddha Patil
Zuventus Healthcare Limited, Plot No. P-2, SBM, Ground Floor (Part-B) and First Floor.
I.T.B.T. Park, Phase –II, MIDC, Hinjawadi, Pune – 411057, India.
*Corresponding Author

Published In:   Volume - 16,      Issue - 1,     Year - 2026


Keywords:

Cite this article:
Bhagyashree Tayade, Vikram Gharge, Balasaheb Jadhav, Anant Patil, Chetan Parde, Shraddha Patil. Critical Parameters affecting Stability of APIs and Drug Products: A Review. Asian Journal of Pharmaceutical Analysis. 2026; 16(1):41-0. doi: 10.52711/2231-5675.2026.00007

  Purchase PDF



Recomonded Articles:

Comparative Study of Kinetics of Saponification of Ethyl Acetate by pH Method and Titration Method

Author(s): Ulhas Balkrishna Hadkar, Asavari Sameer Hadkar

DOI: 10.5958/2231-5675.2018.00004.2         Access: Open Access Read More

Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Albendazole and Ivermectin in Pharmaceutical Dosage form

Author(s): B. Bhavya, P. Nagaraju, V. Mounika, G. Indira Priyadarshini

DOI: 10.5958/2231-5675.2017.00002.3         Access: Open Access Read More

Estimation of Paracetamol in various brands of Paracetamol Tablets and their Comparative Study

Author(s): Vaishali N. Sonawane, Chaitali A. Yeola, Vijayraj N. Sonawane, Khemchand R. Surana1, Dhananjay M. Patil, Deepak D. Sonawane

DOI: 10.52711/2231-5675.2023.00025         Access: Open Access Read More

A Review UV Method Development and Validation

Author(s): Komal P. Shinde, Akash D. Rajmane

DOI: 10.52711/2231-5675.2023.00021         Access: Open Access Read More

UHPLC: Applications in Pharmaceutical Analysis

Author(s): Hamid Khan, Javed Ali

DOI: 10.5958/2231-5675.2017.00020.5         Access: Open Access Read More

Determination of the amount of Simethicone in different Drug formulations by the Gravimetric method and comparison with the FTIR method by Chemometric methods

Author(s): Muge Guleli, Sezin İşsever, Cem Çalışkan, Mahmut Ozbek

DOI: 10.5958/2231-5675.2021.00003.X         Access: Open Access Read More

Review on Stability Indicating Assay Method or Forced Degradation Study: Strategy and Regulatory Consideration

Author(s): Amitkumar J. Vyas, Chirag D. Jadav, Ajay I. Patel, Ashok B. Patel, Sunny R. Shah, Devang Sheth, Sandip Dholakia

DOI: 10.52711/2231-5675.2023.00022         Access: Open Access Read More

A simple HPLC Method for In-Vitro Dissolution study of Brivaracetam in Pharmaceutical Dosage Form

Author(s): Pankaj Bhamare, Rupal Dubey, Neeraj Upmanyu, Pothuvan Umadoss

DOI: 10.5958/2231-5675.2021.00001.6         Access: Open Access Read More

Spectrophotometric method for the Estimation of Cetirizine Hydrochloride in Pharmaceutical preparation

Author(s): S. Subramanya Raj Urs, Bindu M., Ramyashree D., Sowmya K. N.

DOI: 10.5958/2231-5675.2020.00034.4         Access: Open Access Read More

A Brief Review on Quality by Design and Process Analytical Technology

Author(s): Dipti G. Phadtare, Pawar Amol R, R.B. Saudagar

DOI: 10.5958/2231-5675.2016.00019.3         Access: Closed Access Read More

Development and Validation of UV Spectrophotometric Method for Estimation of Benfotiamine in Bulk and Dosage Form

Author(s): Agrawal O.D, Telang N.B

DOI: 10.5958/2231-5675.2016.00020.X         Access: Open Access Read More

Spectrophotometric method of Choline Bitartrate in bulk and its tablet formulation

Author(s): G. Krishnamoorthy, C. Diana Priyadarshini, R. Senthamarai

DOI:         Access: Open Access Read More

Glimepiride: A Review of Analytical Methods

Author(s): Shobha Rani G, Lohita M, Jaya Preethi P, Madhavi R, Sunisitha B, Mounika D

DOI:         Access: Open Access Read More

A Review on Carcinogenic Impurities Found in Marketed Drugs and Strategies for its Determination by Analytical Methods

Author(s): Amitkumar J. Vyas, Jayshree P. Godhaniya, Ajay I. Patel, Ashok B. Patel, Nilesh K. Patel, Alpesh Chudasama, Sunny R. Shah

DOI: 10.52711/2231-5675.2021.00028         Access: Open Access Read More

RP-HPLC Method Development and Validation for Simultaneous Estimation of Lignocaine Hydrochloride and Clotrimazole Hydrochloride in Ear Drops

Author(s): Kumaraswamy. Gandla, D. Sudheer Kumar, Joru Praveen, Emmadi Suman

DOI: 10.5958/2231-5675.2017.00026.6         Access: Open Access Read More

Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Linagliptin, Empagliflozin and Metformin in Solid Dosage Forms

Author(s): T. Naga Ravi Kiran, P. Parvathi, J.N. Suresh Kumar

DOI: 10.5958/2231-5675.2020.00021.6         Access: Open Access Read More

UV Spectrophotometric Method Development and Validation for the Estimation of Valsartan in Bulk and Pharmaceutical Dosage Form

Author(s): Saroj Kumar Raul, Gopal Krishna Padhy, Pramudula Ramya Krishna, Boddu Uma Madhu Priya

DOI:         Access: Open Access Read More

Simultaneous UV Spectrophotometric Estimation and Validation of Rutin and resveratrol in combined dosage form by Iso absorptive point method

Author(s): Devi Violina, Bhupen Kalita

DOI: 10.5958/2231-5675.2018.00027.3         Access: Open Access Read More

Design and Validation of Dissolution Profile of Rivaroxaban by Using RP-HPLC Method in Dosage Form

Author(s): Pinaz A. Kasad, K.S. Muralikrishna

DOI:         Access: Open Access Read More

UV Spectrophotometric Method Development and Validation for the Estimation of Gliclazide in Bulk and Pharmaceutical Dosage Form

Author(s): Saroj Kumar Raul, Bukkuru Spandana, Patibandla Sameera, Vegiraju Vikitha

DOI:         Access: Open Access Read More

Asian Journal of Pharmaceutical Analysis (AJPA) is an international, peer-reviewed journal, devoted to pharmaceutical analysis...... Read more >>>

RNI: Not Available                     
DOI: 10.5958/2231–5675 

Quick Links


Latest Issues

Popular Articles


Recent Articles



Analytical Quality by Design-Based RP-HPLC Method for Simultaneous Estimation of Lobeglitazone sulfate and Glimeperide in Pharmaceutical Formulations
Beyond Chromatograms: Green Analytical Frontiers in the Nutraceutical Era
Method Development and Validation for the Assay of the Anticoagulant dosage form by HPLC
Validation of the UV Spectrophotometric Method for the Quantitative measurement of Clopidogrel bisulphate in Pharmaceutical Dosage Form and Bulk
Analytical method development and validation for Simultaneous Estimation of Rifampicin and Levofloxacin in Bulk and Synthetic Mixtures Using Validated RP- HPLC Technique
A High-Precision RP–HPLC Method for Ondansetron Hydrochloride: Development, Optimization and Validation
Personalized Medicine: Advancing Precision Medicine used in Autoinflammatory and Related Disorders
Critical Parameters affecting Stability of APIs and Drug Products: A Review
Recent Advances in Bioanalytical Techniques for the Analysis of Phytoconstituents: A Review
Green Quality Assurance for Sustainable Pharmaceuticals
Analytical Method Development and Validation for Estimation of Fimasartan in Bulk Drug and Pharmaceutical Dosage Form
A Comprehensive Review of Analytical Techniques for the Quantification of Metoprolol Succinate
UV-Spectrophotometric Method Development and Determination of Suitable Medium for Cholroxazone by Comparing In-Between Three Body Fluids
UHPLC Technology: Recent Developments and Emerging Applications in Analytical Chemistry
Benidipine Hydrochloride: A Triple-Action Calcium Channel Blocker for Superior Hypertension Management – Pharmacological Insights, Analytical Techniques, and Future Perspectives
Influence of Apparatus Geometry and Environmental Factors on Evaporation Dynamics and Phytochemical Integrity of Ethanolic Extract of Cinnamomum verum
UV-Spectrophotometric Method Development and Determination of Suitable Medium for Dasatinib by Comparing In-Between Three Body Fluids
Analytical Method Development and Validation for Estimation of Ertugliflozin in Bulk Drug and Pharmaceutical Dosage Form by RP-HPLC
Development and Validation of UV Spectroscopic Method for Simultaneous Estimation of Metoprolol Succinate and Cilostazol
Quantification of Tramadol hydrochloride and its Related Substances by HPLC in Pharmaceutical Dosage Form

Tags