Archive

Abstract

Analytical technique’s is a wide-ranging concept covering all matters that individually or collectively influence the quality of the product. Highly specific and sensitive analytical techniques hold the key role to the design, development, standard and quality control of medicinal products. Quality of drug products is very vital, as it involves life. Proper manufacture and quality control of pharmaceuticals is the vital segment of strong primary healthcare program worldwide. Pharmaceutical analysis, a branch of pharmacy, plays a very significant role in quality control of pharmaceuticals through a rigid check on raw materials used in manufacturing of formulation and on finished products. Few analytical methods such as spectroscopic method and chromatographic methods are used for quality control and validation of drugs. In this research article we used RP-HPLC method for development and validation on Olaparib tablets. Olaparib is primarily used for the treatment of ovarian and breast cancer. The purpose of this research is to develop method of a drug and which can be optimized according to different parameter and to validate according to ICH (Q2 R1) guidelines. All the research work was carried out in a systematic, concise, and serial manner which includes a thorough study by literature available for the analysis of Olaparib drug. In this research article we have done optimization of Olaparib tablets using RP-HPLC method with the help of 4 trials for optimization and in validation we have studied about these parameters specificity, linearity, range accuracy, precision, system suitability and robustness.

Keywords

Quality, specificity, optimization, validation

Reference

  1. Skoog, West and Holler: Fundamental of Analytical Chemistry, 7th Edition, Saunders college Publishing 1992(1)
  2. Sharma BK: Instrumental Methods of Chemical Analysis, 16thEdn.Goel Publishing House, Krishna Prakashan Ltd. Meerut. 2004(3)
  3. Beckett AH. and Stanlake JB: Practical Pharmaceutical Chemistry, 4thEdn. Part 2, CBS Publishers and Distributors. New Delhi,2005(1)
  4. Khopkar SM: Basic concepts of analytical chemistry, New age International Ltd. Publishers, New Delhi, 1998(2)178-179.
  5. Settle F: Handbook of Instrumental techniques for analytical chemistry, Prentice Hall PTR, NJ, 1997 17-19, 56-57.
  6. Skoog DA, Holler FJ, Crouch SR, Principle of Instrumental Analysis, Thomson Publications, India, 2007(6)1-3,145-147,180.
  7. Mendham J, Denney RC, Barnes JD, Thomas M: Vogel’s Textbook of Quantitative Analysis. Pearson Education, Singapore, 2003 8-9
  8. Christian GD: Analytical Chemistry, John Wiley and Sons, 2003(5)35-42,131-132.
  9. Gennaro AR, Karen BM, Medwick T, Remington: The Science and Practice of Pharmacy, 19th, the Mack Publishing Company, Pennsylvania, 1995(1)437-490.
  10. Willard HH, Merritt LL, Dean JA, Settle FA: Instrumental Methods of Analysis, 7th Edn, CBS Publisher and Distributors, New Delhi. 2002. 617.
  11. Sethi          PD:      High    Performance    Liquid Chromatography, Quantitative Analysisof Pharmaceutical Formulations, CBS Publishers and Distributors, New Delhi, 2001(1) 3-11, 116-120.
  12. Christen GD, Analytical Chemistry, 5 edi John Wiley & Sons, Inc.2001.505
  13. Weston A, Brown PR: High Performance Liquid Chromatography, Separations in High Performance Liquid Chromatography, Instrumentation for HPLC. In: HPLC and CE – Principles and practice. Academic Press, USA, 1997. 1-4, 8-11, 24-26, 29-32, 71.
  14. Kasture AV, Mahadik KR, Wadodkar SG, More HN, Pharmaceutical Analysis- Instrumental Methods. 2008(l) 6-7, 28-30, 49, 64, 67.
  15. United State Pharmacopeia, USP 29/NF 24, US Pharmacopeial Convention, Inc, Rockville MD, 2006, 555-556, 1777, 1861, 3050- 3052.
  16. Andrew F: - Studied simultaneous analysis of Escitalopram and buproprion-SR by High Performance Liquid Spectroscopy.
  17. Hanretta D. - Studied determination of Escitalopram, with Duloxetine and Olanzapine by reversed phase High Performance Liquid Chromatography.
  18. Elham A. - Studied Micelle Enhanced Fluorimetric and Thin Layer Chromatography Densitometric Methods for the Determination of (±) Citalopram and its S – Enantiomer Escitalopram.
  19. Christine Greiner: - Studied Determination of citalopram and escitalopram together with their active main metabolites desmethyl(es)citalopram in human serum by column- switching high performance liquid chromatography (HPLC) and spectrophotometric detection.
  20. ICH guidelines, analytical method validation (Q3). Geneva, July 2000.
  21. Guidance for industry, Analytical Procedure and Method Validation, U. S. Department of Health and Human Services FDA, (Aug2000)

image
Sudhanshu Kumar Jha
Corresponding author

Central Ayurveda Research Institute, Jhansi, Uttar Pradesh; 284002, Ministry of Ayush, Government of India.

image
Gopal Lohiya
Co-author

Department of Quality Assurance, Dayanand College of Pharmacy, Latur, Maharashtra.

image
Saurabh Rahatkar
Co-author

Department of Quality Assurance, Dayanand College of Pharmacy, Latur, Maharashtra.

image
Rohini Ghotmukale
Co-author

Department of Quality Assurance, Dayanand College of Pharmacy, Latur, Maharashtra.

image
Swapnali Delmade
Co-author

Department of Quality Assurance, Dayanand College of Pharmacy, Latur, Maharashtra

image
Kranti Satpute
Co-author

Department of Quality Assurance, Dayanand College of Pharmacy, Latur, Maharashtra.

image
Sanket Dharashivkar
Co-author

Department of Pharmaceutics, Dr L H Hiranandani College of Pharmacy, Ulhasnagar, Maharashtra.

image
Surendra G. Gattani
Co-author

School of Pharmacy, Swami Ramanand Teerth Marathwada University, Nanded, Maharashtra.

image
Sunny Chauhan
Co-author

GVM College of Pharmacy, Murthal Road, Sonipat, Haryana, India.

image
Divyam Maheshwari
Co-author

Department of Pharmaceutical sciences, Vishveshwarya Group of Institutions, Gautam Buddh Nagar, Uttar Pradesh, India.

Gopal Lohiya, Saurabh Rahatkar, Rohini Ghotmukale, Swapnali Delmade, Kranti Satpute, Sanket Dharashivkar, Surendra G. Gattani, Sunny Chauhan, Sudhanshu Kumar Jha*, Divyam Maheshwari, RP HPLC Method Development and Validation on OLAPARIB Tablets, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 9, 227-240. https://doi.org/10.5281/zenodo.8332607

More related articles
Research advance in clinical evaluation of antihyp...
Vishavjeet Pisal, Tejaswini Kamble, Pritam Salokhe, Sachin Navale...
Enhancing Patient Care With AI Chatbots And Virtua...
Asma Shaikh , Haritha CK, Arina Mullick, Varun Gadia, ...
Formulation And Evaluation of Nanoparticles: A Rev...
Muni Raja Lakshmi K, Lavanya E, Naseema Shaik, Vankata Rao Gadde,...
An Overview On Glaucoma: Silent Thief Of Sight...
Namrata S. Revar, Sanjeevani D. Rupwate, Samruddhi B. Sawant, Sanjana S. Shinde, Sanskruti Malode, ...
Natural Polymers as Excipient in Formulation of Novel Drug Delivery System...
Yukti Mahajan, Dev Raj Sharma, Pravin Kumar, Mahender Singh Ashawat, ...
Related Articles
Application Of Novel Drug Delivery System For Herbal Formulation...
Rutuja Patil, Poonam Madane, Namrata Satkar, Uday Kore, Nilesh B. Chougule, Pranjal D. Chougule, ...
Formulation And Evaluation Of The Various Physicochemical, Rheological, And Stab...
Priyanka S. Sawarkar, Mohit A. Gede, Ankit S. Kediya, M. P. Katwe, M. P. Rathod, R. O. Ganjiwale, ...
Analytical Method Validation of Tablet Dosage Form of Lurasidone HCl...
Dr Anu Jindal, Simranjeet Singh, Muskan Sood, Rajmeet Singh, Satvinder Kaur, Jaswinder Singh, Shavet...
Brand survey-based study of Ciprofloxacin-500 tablet marketing for Tuberculosis...
Ravi Maurya, Ishu Garg, Harish Kumar, Divyanshu Raj, Devbrath Tripathi , ...
Research advance in clinical evaluation of antihypertensive Drug...
Vishavjeet Pisal, Tejaswini Kamble, Pritam Salokhe, Sachin Navale, Nilesh Chougule, ...
More related articles
Research advance in clinical evaluation of antihypertensive Drug...
Vishavjeet Pisal, Tejaswini Kamble, Pritam Salokhe, Sachin Navale, Nilesh Chougule, ...
Enhancing Patient Care With AI Chatbots And Virtual Assistants...
Asma Shaikh , Haritha CK, Arina Mullick, Varun Gadia, ...
Formulation And Evaluation of Nanoparticles: A Review...
Muni Raja Lakshmi K, Lavanya E, Naseema Shaik, Vankata Rao Gadde, ...
Research advance in clinical evaluation of antihypertensive Drug...
Vishavjeet Pisal, Tejaswini Kamble, Pritam Salokhe, Sachin Navale, Nilesh Chougule, ...
Enhancing Patient Care With AI Chatbots And Virtual Assistants...
Asma Shaikh , Haritha CK, Arina Mullick, Varun Gadia, ...
Formulation And Evaluation of Nanoparticles: A Review...
Muni Raja Lakshmi K, Lavanya E, Naseema Shaik, Vankata Rao Gadde, ...