Author(s): D. Prashanthi, B. Ramesh, Manish

Email(s): prashanthireddy.h@gmail.com

DOI: 10.52711/0974-360X.2022.00756   

Address: D. Prashanthi1, B. Ramesh2, Manish3
1Assistant Professor, Sree Siddaganga College of Pharmacy, Dept of QA, Tumkur - 572102 (Karnataka), India.
2Principal and Professor, Sri Adichunchanagiri College of Pharmacy, B.G Nagar, Mandya.
3Assistant Professor, Sri Adichunchanagiri College of Pharmacy, B.G Nagar, Mandya.
*Corresponding Author

Published In:   Volume - 15,      Issue - 10,     Year - 2022


ABSTRACT:
A new simple, sensitive, rapid, precise, suitable and cost-effective reversed-phase stability indicating HPLC method was developed and validated in compliance with ICH Q2R1 guidelines for the simultaneous estimation of the Perindropil and Amlodipine in the fixed dose pharmaceutical formulation. The effective chromatographic separation was achieved with 0.1% TEA buffer of PH 4.5 and Acetonitrile in the ratio of 65:35 as mobile phase, at a flow rate of 1.0ml/min on HPLC system containing UV- detector with Xbridge column (150x4.6 mm; 5µ). The detection was carried out at 237nm. The retention time was found to be 3.089 and 4.201 min for Perindropil and Amlodipine respectively. The optimized method gave the good resolution and suitable retention time. The linear range was 8-40µg/ml for Perindropil (r2 = 0.998) and 10-50µg/ml for Amlodipine (r2 = 0.998). Percentage recoveries were found to be 99.58% and 100.4% for Perindropil and Amlodipine respectively. The method was statistically validated and all the analytical validation parameters were found to be within the limits indicating the validity of the method. %RSD was found to be less than 2.0 indicating high degree of accuracy and precision. Both the drugs were subjected to acid and base hydrolysis, oxidation, heat and photolysis to apply the stress. The degradation studies indicated that the drugs were susceptible under various degradation conditions thus indicating that the degradation of drugs had occurred. Thus the proposed method can be applied for the simultaneous estimation of the Perindropil and Amlodipine in the marketed formulation.


Cite this article:
D. Prashanthi, B. Ramesh, Manish. Development of Novel Validated RP-HPLC Method for the simultaneous determination of Perindropil and Amlodipine with possible degradants in Fixed dose Pharmaceutical Formulation. Research Journal of Pharmacy and Technology2022; 15(10):4509-4. doi: 10.52711/0974-360X.2022.00756

Cite(Electronic):
D. Prashanthi, B. Ramesh, Manish. Development of Novel Validated RP-HPLC Method for the simultaneous determination of Perindropil and Amlodipine with possible degradants in Fixed dose Pharmaceutical Formulation. Research Journal of Pharmacy and Technology2022; 15(10):4509-4. doi: 10.52711/0974-360X.2022.00756   Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2022-15-10-29


REFERENCES:
1.    The Merck Index, 13th Edition, Code 7247 (Perindopril), 491 (Amlodipine), 86 (2001) p. 1286.
2.    Asian Guideline for Validation of Analytical Procedure Adopted from ICH guidelines, Q2A27 Oct. 1994 and ICH Q2B, 6th Nov. 1994.
3.    Gandla. Kumara Swamy, N. Ravindra, S. Sowmya. A New RP-HPLC Method Development and Validation for the Simultaneous Estimation of Amlodipine and Valsartan in Tablet Dosage Forms. Asian J. Pharm. Ana. 4(3): July-Sept. 2014; Page 103-107.
4.    Introduction to Perindropil, (online):URL:http://en.wikipedia.org/wiki/ Perindropil.
5.    Introduction to Amlodipine, (online):URL:http://en.wikipedia.org/wiki/ Amlodipine.
6.    Sravani Koralla, Sathish Kumar Konidala, K Govinda Rao, Sheik Mobina Begum. Stability Indicating RP-HPLC Method For Simultaneous Estimation of Ramipril and Amlodipine Besylate in Pharmaceutical Dosage Form. Asian J. Pharm. Res. 2016; 6(4): 242-249.
7.    SS Chitlange, Kiran Bagri, DM Sakarkar. Stability Indicating RP- HPLC Method for Simultaneous Estimation of Valsartan and Amlodipine in Capsule Formulation. Asian J. Research Chem. 2008; 1(1): 15-18.
8.    Amrish Sharma, Mukul Tailang, Bhaskar Gupta, Ashish Acharya. RP HPLC Determination of Amlodipine in Its Pharmaceutical Dosage Forms. Asian J. Research Chem. 2010; 3(1): 129-131.
9.    Blessy M, Patel RD and Prajapati PN, Agrawal YK, Development of forced degradation and stability indicating studies of drugs: A review, Journal of Pharmaceutical Analysis. , 2013; 09: 03 pages.
10.    M. Jagadeeswaran, N. Gopal, T. Sivakumar. Simultaneous Estimation and Validation of Amlodipine Besylate and Nebivolol Hydrochloride in Tablet Formulation by RP-HPLC Method. Asian J. Research Chem. 2010; 3(3): 640-642.
11.    Ravinder Burugu, G. Venkateshwarlu. RP-HPLC Determination of Amlodipine Besylate and Atorvastatin from Tablets Dosage forms. Asian J. Research Chem. 2010; 3(3): 763-766.
12.     Ragine Maheswaran. FDA Perspectives: Scientific Considerations of Forced Degradation Studies in ANDA Submissions. Pharmaceutical Technology. 2012; 36:73-80.
13.    Hassan SA,  Nashat NW,  Elghobashy MR,  Abbas SS,  Moustafa AA. Stability-Indicating RP-HPLC and CE Methods for Simultaneous Determination of Bisoprolol and Perindopril in Pharmaceutical Formulation: A Comparative Study. JCS. 2020; 58(8):747 758. Doi: https://doi.org/10.1093/chromsci/bmaa031.
14.    P. Haritha, B. Sreenivasa Rao, Y. Sunandamma. Method Development and Validation for Simultaneous Determination of Amlodipine Besylate and Atorvastatin Calcium by RP–HPLC Technique. Asian J. Research Chem. 2014; 7(4): 438-445.
15.    S. Ashutosh Kumar, Manidipa Debnath, J.V.L.N. Seshagiri Rao, D. Gowri Sankar. Stability indicating Method Development and Validation for simultaneous estimation of Hydrochlorothiazide, Amlodipine and Olmesartan in tablet dosage form by using RP-HPLC. Asian J. Research Chem. 2014; 7(5): 538-548.
16.    Kansara DA, Chhalotiya UK, KachhiyaHM, Patel IM, Shah DA. Simultaneous estimation of amlodipine besylate, Rosuvastatin calcium and Fimasartan potassium trihydrate combination used in the treatment of hypertension using LC method. SN Applied Sciences. 2020; 2:948. Doi: https://doi.org/10.1007/s42452-020-2758-4.
17.    N.I. Kochar, M.N. Dahake, R.L. Bakal, A.P. Devani, A.V.Chandewar. Method Development and Validation of Ramipril and Amlodipine Besylate by RP-HPLC. Asian J. Research Chem. 2011; 4(12): 1829-1832.
18.    Badar H, Yasmeen R, Ayeen FQ, Badar J. Method Development and Validation for the Analysis of Perindopril Erbumine and Amlodipine Besylate by RP-HPLC in Pure and Pharmaceutical Dosage Form. RJPT. 2020; 13 (5):2163-2166. DOI: 10.5958/0974-360X.2020.00389.3.
19.    Mohan TSSJ, Jogia HA, Mukkanti K. Novel Stability-Indicating UHPLC Method Development and Validation for the Quantification of Perindopril, Amlodipine and Their Impurities in Pharmaceutical Formulations: Application of QbD Approach. Chromatographia. 2020; 8(3):1197-1220.
20.    Bhatia Neela Manish, Deshmane Snehal Jawaharlal, More Harinath Nivrutti, Choudhari Praffula Balkrishna. Validated RP-HPLC Method for Simultaneous Determination of Amlodipine Besylate and Hydrochlorothiazide from Pharmaceutical Preparation and Biological Samples. Research J. Pharm. and Tech. 2009; 2 (3): 482-486.
21.    J. Priyadharisini, D. Saraswathi, Ajitha Aruna, A. Jerad Suresh. RP-HPLC Determination of Olmesartan Medoxomil and Amlodipine Besylate in tablets. Research J. Pharm. and Tech. 2011; 4(6): 903-904.

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