Simultaneous estimation of chlorthalidone and efonidipine hydrochloride in bulk and tablet dosage form

N.A.

Makale detayları

Simultaneous estimation of chlorthalidone and efonidipine hydrochloride in bulk and tablet dosage form

Yazarlar:

N.A.

Yayıncı:

Marmara University

Ana Başlıklar:

Pharmaceutical Analytical Chemistry | Pharmaceutical Delivery Technologies | Pharmacology and Pharmaceutical Sciences (Other)

Dergi:

Journal of Research in Pharmacy Vol.28 Issue 5, pp.1449-1457

Belge Tipi:

Makale

Yayın Tarihi:

6/2025

Belge Dili:

İngilizce

Document ID (Org No.):

2001347575

pISSN:

2630-6344

Anahtar kelimeler:

Özet:

 Chlorthalidone and efonidipine hydrochloride are anti-hypertensive agents with different mechanisms of action. These drugs are generally used as monotherapy; however, recent study suggests their use in combination reduces the mortality rate. Based on this evidence, Zuventus Healthcare limited developed a combination dosage Efnocar Ct which has been recently approved for its use. Hence, a new, sensitive, precise and robust method was developed and validated to determine the purity of the compounds in bulk as well as tablet dosage forms. The HPLC analysis was achieved on Zobrax 150 column using acetonitrile and ammonium formate 60:40 vv as the mobile phase and the detection was achieved at a λ max of 248nm. The linearity was achieved between the concentration range of 3µgml  18µmml for chlorthalidone and 10µgml  60µgml concentration range for efonidipine hydrochloride. The  recovery for chlorthalidone was 100.03 and that for efonidipine was 100.24, indicating the method to be accurate. The LOD and LOQ values for chlorthalidone was 0.01µgml and 0.02µgml and for efonidipine it was 0.26µgml and 0.88µgml. This indicates the sensitivity of the method. Robustness studies have shown no significant variations and degradation studies have shown acceptable results. The results of the proposed method for linearity, accuracy, sensitivity and robustness were within the acceptable limits.

 Chlorthalidone and efonidipine hydrochloride are anti-hypertensive agents with different mechanisms of action. These drugs are generally used as monotherapy; however, recent study suggests their use in combination reduces the mortality rate. Based on this evidence, Zuventus Healthcare limited developed a combination dosage Efnocar Ct which has been recently approved for its use. Hence, a new, sensitive, precise and robust method was developed and validated to determine the purity of the compounds in bulk as well as tablet dosage forms. The HPLC analysis was achieved on Zobrax 150 column using acetonitrile and ammonium formate 60:40 vv as the mobile phase and the detection was achieved at a λ max of 248nm. The linearity was achieved between the concentration range of 3µgml  18µmml for chlorthalidone and 10µgml  60µgml concentration range for efonidipine hydrochloride. The  recovery for chlorthalidone was 100.03 and that for efonidipine was 100.24, indicating the method to be accurate. The LOD and LOQ values for chlorthalidone was 0.01µgml and 0.02µgml and for efonidipine it was 0.26µgml and 0.88µgml. This indicates the sensitivity of the method. Robustness studies have shown no significant variations and degradation studies have shown acceptable results. The results of the proposed method for linearity, accuracy, sensitivity and robustness were within the acceptable limits.

 Chlorthalidone and efonidipine hydrochloride are anti-hypertensive agents with different mechanisms of action. These drugs are generally used as monotherapy; however, recent study suggests their use in combination reduces the mortality rate. Based on this evidence, Zuventus Healthcare limited developed a combination dosage Efnocar Ct which has been recently approved for its use. Hence, a new, sensitive, precise and robust method was developed and validated to determine the purity of the compounds in bulk as well as tablet dosage forms. The HPLC analysis was achieved on Zobrax 150 column using acetonitrile and ammonium formate 60:40 vv as the mobile phase and the detection was achieved at a λ max of 248nm. The linearity was achieved between the concentration range of 3µgml  18µmml for chlorthalidone and 10µgml  60µgml concentration range for efonidipine hydrochloride. The  recovery for chlorthalidone was 100.03 and that for efonidipine was 100.24, indicating the method to be accurate. The LOD and LOQ values for chlorthalidone was 0.01µgml and 0.02µgml and for efonidipine it was 0.26µgml and 0.88µgml. This indicates the sensitivity of the method. Robustness studies have shown no significant variations and degradation studies have shown acceptable results. The results of the proposed method for linearity, accuracy, sensitivity and robustness were within the acceptable limits.

 Chlorthalidone and efonidipine hydrochloride are anti-hypertensive agents with different mechanisms of action. These drugs are generally used as monotherapy; however, recent study suggests their use in combination reduces the mortality rate. Based on this evidence, Zuventus Healthcare limited developed a combination dosage Efnocar Ct which has been recently approved for its use. Hence, a new, sensitive, precise and robust method was developed and validated to determine the purity of the compounds in bulk as well as tablet dosage forms. The HPLC analysis was achieved on Zobrax 150 column using acetonitrile and ammonium formate 60:40 vv as the mobile phase and the detection was achieved at a λ max of 248nm. The linearity was achieved between the concentration range of 3µgml  18µmml for chlorthalidone and 10µgml  60µgml concentration range for efonidipine hydrochloride. The  recovery for chlorthalidone was 100.03 and that for efonidipine was 100.24, indicating the method to be accurate. The LOD and LOQ values for chlorthalidone was 0.01µgml and 0.02µgml and for efonidipine it was 0.26µgml and 0.88µgml. This indicates the sensitivity of the method. Robustness studies have shown no significant variations and degradation studies have shown acceptable results. The results of the proposed method for linearity, accuracy, sensitivity and robustness were within the acceptable limits.

Makale detayları

Simultaneous estimation of chlorthalidone and efonidipine hydrochloride in bulk and tablet dosage form

Yazarlar:

N.A.

Yayıncı:

Marmara University

Ana Başlıklar:

Pharmaceutical Analytical Chemistry | Pharmaceutical Delivery Technologies | Pharmacology and Pharmaceutical Sciences (Other)

Dergi:

Journal of Research in Pharmacy Vol.28 Issue 5, pp.1449-1457

Belge Tipi:

Makale

Yayın Tarihi:

6/2025

Belge Dili:

İngilizce

Document ID (Org No.):

2001347575

pISSN:

2630-6344

Hypertension

combination dose

chlorthalidone

efonidipine hydrochloride

method development

validation

Sayı

Makale detayları

Simultaneous estimation of chlorthalidone and efonidipine hydrochloride in bulk and tablet dosage form

Yazarlar: N.A.

Yayıncı: Marmara University

Ana Başlıklar: Pharmaceutical Analytical Chemistry | Pharmaceutical Delivery Technologies | Pharmacology and Pharmaceutical Sciences (Other)

Dergi: Journal of Research in Pharmacy Vol.28 Issue 5, pp.1449-1457

Belge Tipi: Makale

Yayın Tarihi: 6/2025

Belge Dili: İngilizce

Document ID (Org No.): 2001347575

pISSN: 2630-6344

Hypertension

combination dose

chlorthalidone

efonidipine hydrochloride

method development

validation

Sayı

Yazarlar:

N.A.

Yayıncı:

Marmara University

Ana Başlıklar:

Pharmaceutical Analytical Chemistry | Pharmaceutical Delivery Technologies | Pharmacology and Pharmaceutical Sciences (Other)

Dergi:

Journal of Research in Pharmacy Vol.28 Issue 5, pp.1449-1457

Belge Tipi:

Makale

Yayın Tarihi:

6/2025

Belge Dili:

İngilizce

Document ID (Org No.):

2001347575

pISSN:

2630-6344