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RP-HPLC–PDA Approach for Concurrent Analysis of Telmisartan and Azelnidipine in Bulk and Commercial Tablets

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Abstract

Objective

The foremost purpose of the planned research was to develop and validate a cost-effective, sensitive, precise and trouble-free RP-HPLC procedure with superior response for the simultaneous analysis of Azelnidipine and Telmisartan in pure blended powder and their fixed-dose combination tablet form.

Method

WATERS reverse phase HPLC instrument with PDA detector was selected to separate Telmisartan and Azelnidipine with fine resolution. Agilent C18 column (150 × 4.6 mm, 5) and a mobile phase composition of 0.1% V/V ortho phosphoric acid in water and acetonitrile (40:60 v/v) were used. Mobile phase was pumped to column with 1 ml/min flow rate and the eluted compounds were detected at 260 nm. The proposed method validated as per ICH specifications. Forced degradation studies were performed with the developed method to ensure the stability of analytes by the proposed method.

Result

The retention times of Azelnidipine and Telmisartan were observed at 2.2 and 2.9 min respectively. Linearity concentrations were observed for Azelnidipine and Telmisartan in the set of 2–12 µg/mL and 20–120 µg/mL respectively. The %RSD of both intraday and inter-day precision was determined in the range of 0.7–1.4. The average percentage recovery of both analytes was in the range of 99.64–100.92%. The results confirmed that the proposed method was cost-effective, precise and trouble-free with superior sensitivity. Study of the percentage degradation both analytes in the presence of various stressed conditions revealed the stability of the current method. Both the drugs were highly acidic sensitive compared with remaining stress conditions such as base hydrolysis, oxidation.

Conclusion

The proposed liquid chromatographic method was highly effective in separation of Azelnidipine and Telmisartan with good sensitivity, lower retention time and economical solvent system. Hence, the proposed method can be considered in pharmaceutical industry.

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Availability of Data and Material

All data and material should be available upon request.

Abbreviations

AZD:

Azelnidipine

TLM:

Telmisartan

FD:

Forced Degradation

ICH:

International Committee for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use

RP-HPLC:

Reverse Phase High Performance Liquid Chromatography

LOD:

Limit of Detection

LOQ:

Limit of Quantification

RSD:

Relative Standard Deviation

SD:

Standard Deviation

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Acknowledgements

The authors are thankful to Department of Pharmaceutical Analysis, GITAM University, Vishakhapatnam, and Dr. A. Srinivas Rao, Principal, Bhaskar Pharmacy College, moinabad for his continuous support.

Funding

It is self financed, no funding was sponsored from any organization, funding agency and non -profit research bodies.

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Authors and Affiliations

  1. GITAM Institute of Pharmacy, GITAM Deemed to Be University, Visakhapatnam, India

    Ramreddy Godela & Sowjanya Gummadi

  2. Bhaskar Pharmacy College, Hyderabad, Rangareddy, India

    Ramreddy Godela & Kranthi Kumar Pola

  3. Institute of Pharmaceutical Research, GLA University, Mathura, India

    Shilpi Pathak

  4. MAK College of Pharmacy, Hyderabad, Rangareddy, India

    Rajendra Yagnambhatla

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  1. Ramreddy Godela
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  2. Sowjanya Gummadi
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  4. Kranthi Kumar Pola
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  5. Rajendra Yagnambhatla
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Correspondence to Ramreddy Godela.

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Godela, R., Gummadi, S., Pathak, S. et al. RP-HPLC–PDA Approach for Concurrent Analysis of Telmisartan and Azelnidipine in Bulk and Commercial Tablets. Chemistry Africa 6, 393–403 (2023). https://doi.org/10.1007/s42250-022-00483-5

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  • DOI: https://doi.org/10.1007/s42250-022-00483-5

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