You are hereDevelopment and Validation of HPTLC Method for Simultaneous Estimation of Atorvastatin Calcium and Olmesartan Medoxomil in Tablet Dosage Form
Development and Validation of HPTLC Method for Simultaneous Estimation of Atorvastatin Calcium and Olmesartan Medoxomil in Tablet Dosage Form
6) Robustness and Ruggedness:
There were no significant difference between results obtained by applying the analytical condition established for the method and those obtained in experiments in which some of the conditions were varied slightly. Thus the method was shown to be robust to changes in acetonitrile proportion from 12-18 %. Plates were developed 5 min after spotting and scanned 15 min after development. The ruggedness of the method was checked by using different analysts and days. The relative standard deviation of the results obtained by different analysts using instruments was <2.0%.
7) Solution stability:
To check the stability of the drug by use of the proposed method, freshly prepared solutions of analytes were applied to the plates and developed after intervals of 2 h, 6 h and 12 h. Decomposition of the drugs were not observed during chromatogram development and no change in the peak area of the drugs were observed during solution stability studies.
The proposed method was also evaluated by the assay of test sample of commercially availabletablets of AT and OLM. The % assay (Mean ± S.D) was found to be 99.89 ± 0.14 for AT and102.2 ± 0.11 for OLM
RESULTS AND DISCUSSION
The mobile phase consisting of acetonitrile: chloroform: methanol: 10% GAA (7:2:1.5:0.1, v/v/v/v) gave Rf value of 0.50±0.01 and 0.76±0.02 for AT and OLM, respectively. The linear regression data (n=5, Table 1) showed a good linear relationship over a concentration range of 200-800 ng/spot for AT and 400-1600 ng/spot for OLM, respectively. The limit of detection and limit of quantification for AT was found to be 178.23 and 540.11 ng/spot and for OLM 40.1 and 121.51ng/spot, respectively. The intra-day and inter-day coefficients of variation were less than 2 for both AT and OLM. Repeatability of sample application was assessed by spotting 5µl of drug solution 5 times on a TLC plate followed by development of plate and recording the peak area for 5 spots. The %RSD for peak area values of AT and OLM were found to be 1.09 and 1.06, respectively. To confirm the specificity of the proposed method, the solution of the formulation was spotted on the TLC plate, developed and scanned. It was observed that the excipients present in the formulation did not interfere with the peaks of drugs. Multiple recovery study was carried out for accuracy parameter. % recovery was found to be within the limit as listed in Table 2. The assay value for marketed formulation was found to be within the limits as listed in Table 3.
The developed HPTLC technique is simple, precise, specific and accurate and the statistical analysis proved that method is reproducible and selective for the analysis of olmesartan medoxomil and atorvastatin calcium in bulk drug and tablet formulation.
The authors wish to express their gratitude to Sun Pharmaceutical Ltd. Baroda (India), for providing gift sample of AT and OLM. The authors are also thankful to the Principal and Management, Shri Sarvajanik Pharmacy College for providing necessary facilities.
1. Budavari S. The Merck Index An encyclopedia of chemicals, drugs and biological. 14th ed. Merck Research Laboratories; 2004. p.668, 1428, 6859.
2. Colin D. Therapeutic drugs. 2nd ed. Churchill Livingstone; 1999. Vol-I A151, A154.
3. Indian Pharmacopoeia. The Indian Pharmacopoeia Commission, Ghaziabad, Govt. of India Ministry of Health and Family Welfare; 2007. Volume 1.Appendix 2.5.3. p. 182-183, 749-752.
4. Warner GT, Javis B. Olmesartan Medoxomil. Drugs; 2002; 62:1345-55.
5. Yoshida K, Kohzuki M. Clinical and Experimental aspects Olmesartan Medoxomil, a new angiotensin-II receptor antagonist. Cardio vascular Drug review 2004; 22:285-308.
6. Erk N. Extractive Spectrophotometric Determination of Atorvastatin in Bulk and Pharmaceutical Formulations. Analytical Letters 2003; 36:2699–2711
7. Nagaraju P, Gopal NV, Srinivas VDN, Padma SVN. Spectrophotometric Methods for the Determination of Atorvastatin Calcium in Pure and it’s Pharmaceutical Dosage Forms. Asian J. Research Chem. 2008; 1:64-6
8. Rajeswari KR, Sankar GG, Rao AL, Seshagirirao JVLN, Nageshwara P. Development and Validation of RP-HPLC method for the estimation of Atorvastatin in tablet dosage form. International Journal of Chemical Sciences 2006; 4: 167-70
9. Erturkn S, Aktas ES, Ersoy L, Fieieioglu S. HPLC method for the determination of atorvastatin and its impurities in bulk drug and tablets. Journal of Pharmaceutical and Biomedical Analysis 2003; 33:1017-23
10. Zaheer Z, Farooqui MN, Mangle AA, Nikalje AG. Stability-indicating high performance liquid chromatographic determination of atorvastatin calcium in pharmaceutical dosage. African Journal of Pharmacy and Pharmacology 2008; 2:204 10
11. Patil UP, Gandhi SV, Sengar MR, Rajmane VS. A validated densitometric method for Analysis of telmisartan and atorvastatin calcium in fixed dose combination. Journal of Chilean chemical society 2010; 55:94-6
12. Celebier M, Altinoz S.Determination of Olmesartan medoxomil in tablets by UV Vis spectrophotometry. Pharmazie 2007; 62:419–22
13. Caglar S, Onal A. Two simple and rapid spectrophotometric methods for the determination of a new antihypertensive drug olmesartan in tablets. Journal of Analytical Chemistry 2010; 65:239-43
14. Hong C, Cheng-xiao MA, You-cheng Z. Determination of the Dissolutions of Two Components in Compound Olmesartan Medoxomil Tablets by New Vierordt Method.Progress. Pharmaceutical Sciences 2006; 12:006
15. Sharma RN, Pancholi SS. RP-HPLC-DAD method for determination of Olmesartan medoxomil in bulk and tablets exposed to forced conditions. Acta Pharm 2010; 60:13 24
16. Trivedi P, Kartikeyan C, Kachave R, Bhadane R. Stability-Indicating Assay Method for Estimation of Olmesartan Medoxomil and its Metabolite. Journal of Liquid Chromatography & Related Technologies 2009; 32:1516-26
17. Rane VP, Patil KR, Sangshetti JN, Yeole RD. Stability-Indicating LC Method for the Determination of Olmesartan in Bulk Drug and in Pharmaceutical Dosage Form. Chromatographia 2008
18. Bajerski L,Rossi CR, Dias CL, Bergold A, Froehlich PE. Stability-Indicating LC Determination of a New Antihypertensive, Olmesartan medoxomil in Tablets. Chromatographia 2008; 68:991–6
19. Shah NJ, Suhagia BN, Shah RR and Patel NM. Developmnet and validation of a Simultaneous HPTLC Method for the estimation of Olmesartn Medoxomil And Hydrochlorthiazide in Tablet Dosage Form. Indian Journal of Pharmaceuticle Sciences 2007; 69:834-6
20. Tambe RS , Shinde RH , Gupta LR, Pareek V, Bhalerao S.B. Development of LLE and SPE procedures and its Applications for determination of olmesartan In human plasma using RP-HPLC AND HPTLC. Journal of Liquid Chromatography & Related Technologies 2010; 33:423–30
21. ICH, Q2A, Hamonised Tripartite Guideline, Test On Validation of Analytical Procedures, IFPMA, in: Proceedings of the International Conference on Harmonization, Geneva, March, 1994.
22. ICH, Q2B, Hamonised Tripartite Guideline, Validation of Analytical Procedure: Methodology, IFPMA, in: Proceedings of the International Conference on Harmonization, Geneva, March, 1996.
NOW YOU CAN ALSO PUBLISH YOUR ARTICLE ONLINE.
SUBMIT YOUR ARTICLE/PROJECT AT email@example.com
FIND OUT MORE ARTICLES AT OUR DATABASE