Author(s): Rajitha Galla, Susmitha Aggarapu, Gireesh Kumar Eri, Geetha Susmita Adepu, Mounika Jampani, Padma Sree Yellamraju, Swarnalatha Dugasani

Email(s): aggarapusuma@gmail.com

DOI: 10.52711/2231-5691.2026.00041   

Address: Rajitha Galla1, Susmitha Aggarapu1,2*, Gireesh Kumar Eri2, Geetha Susmita Adepu2, Mounika Jampani2, Padma Sree Yellamraju2, Swarnalatha Dugasani2
1Institute of Pharmaceutical Technology, Sri Padmavati Mahila Visvavidyalayam, Tirupati - 517502, Andhra Pradesh, India.
2Annamacharya College of Pharmacy, Rajampet - 516126 Andhra Pradesh, India.
*Corresponding Author

Published In:   Volume - 16,      Issue - 3,     Year - 2026


ABSTRACT:
Analytical instruments are used to perform quality control tests and measurements in pharmaceutical laboratories, impacting decisions related to quality of products and their approval by regulatory authorities such as Food and drug administration (FDA). Therefore, their qualification is of paramount importance in maintaining product quality, patient safety, and regulatory compliance. It helps in ensuring that pharmaceutical products are safe, effective, and free from defects, ultimately protecting the health and well-being of patients. Also, it ensures that the qualified instruments foster continuous improvement in their performance which contribute to accurate testing of drug substances and their products, quality assurance and preventing the release of substandard products into the market. This critical review delves into the multifaceted process of qualifying analytical instruments, emphasizing the significance of accuracy, reliability, and adherence to established guidelines. The article explores regulatory requirement and qualification stages of instruments/equipment such as design qualification, installation qualification, operational qualification, performance qualification for the majorly used instruments like electronic balance, pH meter, UV-visible spectrophotometer, fourier transform infra-red spectrophotometer (FTIR), high performance liquid chromatograph (HPLC), gas chromatograph (GC) and high performance thin layer chromatograph (HPTLC). By comprehensively evaluating these aspects, this review highlights the pivotal role of qualification of instruments in sustaining the integrity of testing pharmaceutical samples.


Cite this article:
Rajitha Galla, Susmitha Aggarapu, Gireesh Kumar Eri, Geetha Susmita Adepu, Mounika Jampani, Padma Sree Yellamraju, Swarnalatha Dugasani. Ensuring Accuracy and Reliability in Testing the Quality of Pharmaceutical Compounds: A Review on Qualification of Analytical Instruments with their Applications. Asian Journal of Pharmaceutical Research. 2026; 16(3):275-4. doi: 10.52711/2231-5691.2026.00041

Cite(Electronic):
Rajitha Galla, Susmitha Aggarapu, Gireesh Kumar Eri, Geetha Susmita Adepu, Mounika Jampani, Padma Sree Yellamraju, Swarnalatha Dugasani. Ensuring Accuracy and Reliability in Testing the Quality of Pharmaceutical Compounds: A Review on Qualification of Analytical Instruments with their Applications. Asian Journal of Pharmaceutical Research. 2026; 16(3):275-4. doi: 10.52711/2231-5691.2026.00041   Available on: https://asianjpr.com/AbstractView.aspx?PID=2026-16-3-9


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DOI: 10.5958/2231-5691.2020.00021.0         Access: Open Access Read More

Author(s): Subhashis Debnath, C. Navya Yadav, N. Nowjiya, M. Prabhavathi, A. SaiKumar, P. Sai Krishna, M. Niranjan Babu

DOI: 10.5958/2231-5691.2019.00009.1         Access: Open Access Read More

Author(s): Sarika V. Khandbahale

DOI: 10.5958/2231-5691.2019.00021.2         Access: Open Access Read More

Author(s): Sahil Hasan, Saloni Bhandari, Anshu Sharma, Poonam Garg

DOI: 10.52711/2231-5691.2021.00047         Access: Open Access Read More

Author(s): Ashok B. Patel, Yash D. Dabgar, Ajay I. Patel, Amitkumar J. Vyas, Ashvin V. Dudhrejiya, Nilesh K. Patel

DOI: 10.52711/2231-5691.2023.00048         Access: Open Access Read More

Asian Journal of Pharmaceutical Research (AJPRes.) is an international, peer-reviewed journal, devoted to pharmaceutical sciences. AJPRes. publishes Original Research Articles, Short Communications..... Read more >>>

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DOI: 10.5958/2231–5691 


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